Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
The APC Medical E4162, E4164, E4165 and E4166 external pacemaker models incorporate a design feature whereby the pacing rate will increase by approximately 20ppm, when either the battery voltage becomes low, or when electromagnetic interference is sensed. In both instances the mode of pacing changes from demand to asynchronous pacing. The original intention of this design feature was to avoid competitive pacing and pacing on the T-wave (initiating VT/VF), by increasing the set paced rate by approximately 20ppm.Some patients however may not tolerate such a sudden increase in pacing rate, which may be detrimental to their condition (eg open-heart surgery, valve replacement, congestive heart failure, myocardial infarction, arrhythmia etc). MDA became aware of an incident involving one of the above devices, where the design feature initiated an unexpected change in pacing therapy, which could be inappropriate for certain patients. In the device concerned, failure analysis determined an internal component failure in the battery monitoring circuit. This resulted in inaccurate detection of the battery voltage, which was incorrectly sensed as low. This initiated asynchronous pacing and an increase in pacing rate by an additional 20ppm. The clinician concerned was unaware of the device feature.The APC Medical E4162, E4164, E4165 and E416 pacemakers were designed and manufactured over 20 years ago and therefore clinicians may not be familiar with all the instructions for use, which may not be readily accessible. The design feature common to the above models is not widely used in modern external pacemakers, which incorporate different warning systems to alert users to low battery voltage or the presence of electromagnetic interference.MDA has previously advised that some external pacemakers (including APC model E4162) are susceptible to interference from mobile communications systems 1,2,3 and care should be taken to ensure that patients supported via external pacemakers are not exposed to electromagnetic fields from mobile phones, walkie-talkies etc. MDA has also previously advised that older external pacemaker models should be withdrawn and replaced. 4,5 APC Medical advises that E4162, E4164, E4165 and E416 models have a 15-year service life expectancy and recommends their replacement at the end of that period.Consideration should therefore be given to replacing the above models as soon as practicable. Risk managers are reminded of the Controls Assurance Standard - Medical Devices Management (Criterion 18)6, which addresses the replacement of medical devices in detail, extract as follows:For both hospital and community devices, a stage is reached at which replacement must be considered. If any of the following seven criteria apply, the device is no longer serviceable:Worn out beyond economic repair
Damages beyond economic repair
Unreliable (check service history)
Clinically or technically obsolete
Spare parts no longer available
More cost-effective or clinically effective devices have become available
Unable to be cleaned effectively prior to disinfection and/or sterilisation”
Reason
(apc medical ltd) the pacing rate for models e4162, e4164, e4165 and e4166 may increase by 20 pulses per minute and change in pacing mode in some cases. (mda/2003/008).
Action
Be aware that the above external pacemakers will revert to asynchronous mode pacing at a rate of approximately 20 ppm above the pre-set pacing rate, when either the battery voltage is low or electromagnetic interference is sensed.
Ensure that the above devices are not used for patients where a sudden increase in paced rate of 20 ppm, or a change from demand to asynchronous mode pacing, could compromise patient health.
Consider replacing the above pacemaker models (which were designed and manufactured over 20 years ago) as soon as practicable.
When the above external pacemakers are used, ensure also that mobile communication devices are not used in the vicinity, especially during patient transfer.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
MHRA is aware of five incidents in the United Kingdom where the use of diamorphine solution has resulted in malfunction of the SynchroMed® pump. In four of these incidents, pump malfunction led to cessation of drug delivery (motor stalling) resulting in return of patient symptoms. In the remaining incident (still under investigation) pump malfunction led to over-infusion of diamorphine solution and the patient suffered a cardiorespiratory arrest.Failure analysis of the four cases of motor stalling by Medtronic has shown that motor stalling was associated with the long-term administration of diamorphine solution, where the materials of the internal components were damaged. Diamorphine (diacetyl morphine) in aqueous solution will degrade over time, producing an insoluble active compound (6-monoacetyl morphine), which is an acetate and is believed to have caused the damage to the pump.Current Instructions for Use for the SynchroMed® implantable drug pump do not include diamorphine in the list of medications that are compatible with the pump.In October 2002 Medtronic distributed an “Educational Brief: Revised Drug Formulation SynchroMed® Infusion System”, which listed drugs and additives known to be incompatible with the SynchroMed® implantable drug pump. Diamorphine was not included in this listing since its adverse effect had not been recognised at that time. To clarify this situation Medtronic plans to distribute further information shortly.It is estimated that there are 1200 SynchroMed® drug pumps currently implanted in the UK.
Reason
(medtronic) diamorphine solution is incompatible with the implantable drug pump. (mda/2003/035).
Action
For patients currently receiving diamorphine solution via the SynchroMed® pump, clinicians should consider :changing to an alternative medication compatible with the pump as soon as possible (note that changing the patient’s medication requires careful assessment and observation by experienced personnel);
elective replacement of the pump when patient management dictates.
Clinicians should be aware that other drugs are contraindicated for delivery via SynchroMed® implantable drug pumps. Where doubt exists, check the instructions for use as supplied with the pump, or seek manufacturer’s advice.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Cup wear and asymptomatic acetabular osteolysis.
six hospitals in the uk have informed mhra of poor results and high revision rates associated with abg i acetabular cups. failure modes reported to date include:
increased wear of the ultra-high molecular weight polyethylene (uhmwpe) acetabular cup liner
sever, asymptomatic peri-acetabular osteolysis
cup loosening which in severe cases has led to cup migration into the pelvis.
mhra is also aware of two uk clinical centres with 'kaplan meier survivorship curves' demonstrating abg i cup survivorship of 90+% at ten years, i.E. less than 10% of the acetabular cups had been revised after ten years. the scandinavian joint registries report similar results associated with this product. currently available worldwide literature reports both good and poor abg i cup performance.
mhra, in co-operation with stryker uk, has co-ordinated a detailed audit of clinical notes and x-rays at three uk hospitals (two reporting poor results and one reporting good results) to determine the reasons for the mixed performance in the uk. using two orthopaedic experts' opinion that a cup should 'definitely' or 'probably' be revised as an endpoint, the implant survivorship for all 340 of the abg i cups reviewed during this audit was 100% at three years and 82.5% at ten years. no one factor could be identified as the initiating factor for higher than anticipated polyethylene wear and poor cup performance (see appendix for further details).
although the reason for the variation in performance of abg i cups is unclear, the mhra audit demonstrated that unacceptable revision rates have been observed at some uk clinical centres. as the failure mode is asymptomatic, mhra recommends that all patients implanted with abg i cups are identified and, where necessary, recalled for clinical and radiological review. all patients with abg i cups should be reviewed regularly to ensure patients requiring revision are identified at the earliest opportunity. in all cases the benefit of radiographic examination should be weighed against the risks from radiation exposure on an individual bases, in line with the requirements of ir(me)r 2000
1
.
this medical device alert has been distributed to gps for information, in the event that any of their patients have received an abg i acetabular cup.
references
1
. si 2000 no 1059. the ionising radiation (medical exposure) regulations 2000.
Action
Identify patients who have received ABG I acetabular cups.
Where the identified patients are already undergoing annual review, including radiographic examination, continue to monitor their progress.
Where the identified patients are not currently undergoing annual review, recall them for clinical assessment, including radiographic examination, on an annual basis.
Radiographic examination should include both A-P and lateral X-rays. Look for evidence of acetabular osteolysis. Where the extent of osteolysis, if present, is unclear from X-rays, consider further investigation using CT.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Potential battery defect; possible rapid depletion, prevalence unknown.
in september 2003 the mhra received a report from a uk hospital of a model 7274 marquis dr implantable cardioverter defibrillator (icd) that was unresponsive to programmer interrogation at a follow-up four months post-implant (i.E. device status could not be determined). the patient was unaware of any change. at one month post-implant this icd had been functioning normally. initial failure analysis by medtronic indicated the battery voltage to be 0v (zero volts), with no attributable fault in the icd's electronics. battery analysis revealed a defect due to damage incurred during manufacturing. subsequently, medtronic confirmed two similar non-uk incidents in which patients experienced localised tissue heating and pain.
in may 2002 a battery in production was first identified with this defect. subsequently in october 2002 two additional batteries used in device production were found to have an identical defect. by march 2003 medtronic had implemented improved manufacturing techniques and quality control testing in order to limit this problem. review of the three explanted icds to date has now shown that some batteries, produced prior to completion of these manufacturing changes and which met original test specifications, may still have a potential to fail.
if a defect is present, rapid battery depletion may take place without prior indication at a non-predictable time after implant, possibly occurring even within the advised three-month follow-up period. (this follow-up period is consistent with manufacturer device labelling). within a few hours there will be a complete loss of device function and patients will not receive therapy from the icd. it is also possible that, as the battery rapidly depletes, patients may experience localised pain and/or heat in the tissues surrounding the icd as energy is dissipated within the device. however, although examination of information available to date shows the frequency of occurrence for this problem to be low (1 in 10,000 worldwide), caution is warranted because of the impact that failure could have on the patient. current overall performance of this family of icds is comparable to other icds.
approximately 31,000 potentially affected devices have been distributed worldwide, with 805 in the uk. affected batteries were not used in any other medtronic model of icd supplied to the uk. no other icd manufacturer uses this battery. the mhra will continue to monitor this problem through the adverse incident reporting system and will issue further advice as appropriate.
Action
Clinicians are advised to:
Identify and return to Medtronic any of the potentially affected devices not yet implanted (see the lists of affected serial numbers under 'Device' section).
Ensure that patients implanted with potentially affected devices are followed up at intervals of no more than three months.
Inform all patients to immediately contact their ICD centre if they experience:
Persistent arrhythmias/resumption of symptoms which remain uncorrected by the ICD and/or
Heating sensations or pain in body tissue surrounding the implant.
For the MHRA recommended actions see above.
DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Repeated exposure to cidex® opa high level disinfectant solution, following manual re-processing of urological instruments, may have resulted in hypersensitivity in some patients with a history of bladder cancer undergoing repeated cystoscopy.
johnson & johnson has issued a product notification, contraindicating the use of cidex® opa for re-processing urological instrumentation for use in patients with a history of bladder cancer. a letter and revised instructions for use were issued on 27 april 2004 to all uk customers that have bought cidex® opa.
a recent post-marketing surveillance review carried out by the company identified that, since the product was introduced in 1999, out of approximately 1 million urological procedures world-wide, there have been reports of 24 patients who have experience 'anaphylaxis-like' reactions after repeated cystoscopy (typically after 4-9 treatments). symptoms reported to the manufacturer included nausea, penile swelling, hypotension, vomiting, breathing difficulty, wheezing, rash, hives, eye irritation, dizziness and anaphylactic shock.
in all of the above cases the manufacturer has indicated that the instruments had been manually re-processed. the evidence for manual re-processing being a significant risk factor is, therefore, compelling.
Action
When re-processing urological instruments for use inpatients who have potential for repeated exposure:
Do not use Cidex® OPA if a validated alternative is available.
If no validated alternative to Cidex® OPA is available:
carry out a risk assessment on the continued use of this disinfectant solution;
ensure that measures are in place to minimise disinfectant solution residues (e.g. use of a validated endoscope washer-disinfector);
plan and implement the replacement of this disinfectant solution with an alternative.
Where no validated alternative to Cidex® OPA is available and there is potential for repeated exposure, carry out a risk assessment and options appraisal, taking into account the following factors:
Risk factors
In considering risks to patients:
the risk of sensitisation is related to patterns of exposure. In this instance, repeated cystoscopy and ineffective removal of residues are important risk factors associated with the use of Cidex® OPA;
bladder cancer is associated with reactions to Cidex® OPA, but this is likely to be due to repeated cystoscopy, rather than a risk factor per se. Bladder cancer is not associated with increased susceptibility to allergic disease;
trauma associated with cystoscopy, particularly in male patients, may augment allergic reactions.
In considering risks to users:
the company has identified that healthcare workers have experienced irritation or possible allergic reactions due to exposure to Cidex® OPA. It is the company's view that, in most of these cases, the healthcare workers were not using the product in a manner consistent with the instructions for use;
symptoms reported in healthcare workers do not appear to be indicative of Type I hypersensitivity.
Risk control measures
In the short term, residues of Cidex® OPA should be minimised, preferably by the use of a validated endoscope washer-disinfector cycle. If manual processing is carried out, ensure that the manufacturers' instructions for use are followed, in particular during rinsing.
It is not appropriate to use a sensitiser in circumstances where repeat exposure is a possibility and where such use is avoidable. It is therefore necessary to identify an alternative to Cidex® OPA, a suspected sensitiser, in circumstances where there is potential for repeated exposure to patients. Any alternative must be validated for use and compatible with the device and, where applicable, the endoscope washer-disinfector, in line with each of the respective manufacturer's instructions for use.
Further advice on decontamination, including the selection of materials and processes, is available in MHRA Device Bulletin
DB 2002(05) 'Decontamination of Endoscopes'
and NHS Estates publication HTM 2030 'Washer-Disinfectors - Design considerations'.
[Note: endoscope washer-disinfectors may also be described as automated endoscope re-processors (AER)]
DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Extended charge times and inability to deliver therapy at battery voltages close to elective replacement indicator (eri) for a subset of the above devices.
since 1999 medtronic has issued a series of advisory notices concerning the performance of some gem® dr and micro jewel® ii icds.
medtronic's most recent advisory notice is appended to this alert and updates previous follow-up recommendations for affected gem® dr and micro jewel® ii icds. this most recent advisory notice followed receipt of reports in which appropriate therapy had not been delivered during cardiac arrhythmias. medtronic was concerned that these devices may not be capable of delivering adequate high voltage defibrillation therapy at or near the specified eri at 4.91v, or during the following period to end of life (eol), specified at 4.57v. the mhra is publishing this medical device alert to reiterate the recommendations made by medtronic, and to update and replace advice previously issued by the medical devices agency in ptn no. 80.
Action
Note that the recommendations in this update supersede the advice given in Pacemaker Technical Note (PTN No. 80 issued by the Medical Devices Agency in October 1999.
Identify patients affected by referring to the serial numbers listed in Appendix 2.
Follow the detailed instructions given in Medtronic's Advisory Notice (see Appendix 1).
Carry out the following actions for all affected patients (refer to list of serial numbers):
battery voltage of
5.16V or less
,
charge time of
18 seconds or greater
.
Trust managers should ensure that measures to implement the actions specified above are planned and completed within the following SABS deadlines:
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Previously identified risk from Trilucent breast implants; actions following conclusion of research and update of HN2000(05).The Medical Devices Agency (now part of the Medicines and Healthcare products Regulatory Agency, MHRA) issued two notices about this devices:An Advisory Notice about the voluntary recall of (AN1999(01)This was in response to the Agency identifying concerns about the long-term safety, particularly in relation to the breakdown of the filler material.A Hazard Notice advising that removal of Trilucent breast implants is recommended (HN2000(05)This advice was issued because the preliminary results of toxicological testing indicated that the breakdown products of the soya bean oil filler material were potentially genotoxic.Approximately 4,500 women were implanted with Trilucent breast implants in the UK. As of July 2004, over 3,700 women in the UK have had their Trilucent breast implants removed.In 2000, a programme of research was initiated to investigate any potential risks to women implanted with Trilucent breast implants. This programme was directed, on behalf of AEI Inc, by a panel of independent experts. The programme has recently been completed. The results and conclusions of the research are summarised in Annex 1. A more detailed report of the research programme is available on the Trilucent website (http://www.trilucentinfo.com/) and full details of investigations and results will be published in peer reviewed journals in due course.The independent experts concluded that:the recommendation that Trilucent breast implants should be removed remains appropriate because exposure of local tissue to toxic compounds has been confirmed
there is no evidence for local or systemic disease risk once the implants have been removed
no further studies are needed to assess the potential risk of Trilucent breast implants.The results of the recently completed research programme suggest that there is no significant systemic risk from Trilucent breast implants, whether they are left in place or removed. Therefore, there is no significant risk to the fetus or children of implanted women and there is no evidence to suggest that breastfeeding should be avoided.Although the research programme has been completed, MHRA continues to record and investigate reports of adverse events associated with Trilucent breast implants. If further problems are identified, the MHRA will issue advice.
The independent panel of experts concluded that:the risk of breast implant rupture is low but the shell of Trilucent breast implants may deteriorate more quickly than that of other types of breast implant and the risk of rupture increases with length of time implanted
the filler material undergoes degradation leading to the production of genotoxic breakdown products
there is no evidence of any adverse health effects arising from genotoxic breakdown products
breakdown products were found to bind to DNA in the periprosthetic capsule, confirming exposure of local tissue to genotoxic compounds. However, exposure of mammary tissue or the rest of the body to breakdown products is unlikely and there is no evidence for systemic exposure
any breakdown products would be rapidly metabolised and removed from the body, thus eliminating the risk once the implants have been removed.In summary, the research programme confirmed that women with implants in place can be exposed to genotoxic breakdown products arising from the filler material. However, such exposure is localised to the periprosthetic capsule. There is minimal risk of exposure of breast tissue, other parts of the body, a fetus or breast-fed baby, to genotoxic compounds arising from the filler material.On the bases of these conclusions, it is clear that the recommendation that Trilucent breast implants should be removed remains appropriate. However, there is no significant systemic risk to women who were implanted with Trilucent breast implants, or to their children.
Reason
(lipomatrix inc) conclusions of research after device was recalled for risks of break down of filler and update of hn2000(05). (mda/2004/047).
Action
Inform the Trilucent Care Centre, AEI Inc and MHRA of any incidents associated with the use of Trilucent breast implants.Be aware of the conclusions of the Trilucent research programme (see Annex 1)
Identify women who were implanted with Trilucent breast implants
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Detachment of control threads.
mhra has received 19 reports of detachment of control threads from flexi-t 300 intrauterine devices. most of the reported incidents relate to batch number 01a1. batch details are not available for the remaining incidents. batch 01a1 was manufactured in 2001 and the last uk delivery date for this batch was 01 may 2003.
the control threads may become detached on attempting to remove the device, making removal more difficult.
the manufacturer issued advice to customers in 2003 and issued a reminder in january 2005 (see appendices 1 and 2).
mhra is issuing this alert to ensure that all healthcare professionals involved in the placement and removal of these devices are aware of the manufacturer's advice on how to proceed in cases of difficult removal and on the use of anaesthesia. please note that the local anaesthetic described in the expert report from the manufacturer (appendix 2) is not licensed for this indication in the uk. if a local anaesthetic is necessary, please use an appropriate alternative.
Action
When removing these devices ensure that:
you have read the attached information from the manufacturer
you have access to small clamps for device removal in case of thread detachment.
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
False results may be observed when using this combination of assay and laboratory analyser.
this combination has not been validated by either manufacturer.
the mhra has received a report from a laboratory of an unrepeatable positive hiv test result. the positive result was not confirmed when further routine testing was carried out. the result was generated using a biokit best 2000 laboratory analyser in combination with the biomerieux vironostika hiv uni-form ii ag/ab assay.
the cause of the false result has not been determined. however, biokit has stated that they have not validated this test for use on the analyser and they cannot guarantee the accuracy, reproducibility or performance of this combination. biomerieux has stated that although the analyser meets the specifications set out in their instructions for use, this combination of assay and laboratory analyser has not been validated by them.
Action
Do not use this (or any other) combination of assay and laboratory analyser unless you have verified that the combination of assay and laboratory analyser has been properly validated for safety, quality and performance.
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock.
guidant has identified the potential for loss of therapy in all contak renewal® (model h135) and contak renewal® 2 (model h155) cardiac resynchronization therapy defibrillators (crt-ds) manufactured on or before 26 august 2004.
on delivery of defibrillation therapy the high voltage pulse may discharge (or arc) between the high voltage defibrillation output wire and titanium casing. the resulting high current may damage the crt-d electronics causing one or more of the following:
loss of
arrhythmia detection/ therapy delivery
bradycardia pacing output
telemetry/ programming/ interrogation
partial delivery of intended shock energy.
a red warning screen indicating malfunction
a yellow warning screen indicating 'out of range' shocking impedance.
Action
See actions on page 3.
Ensure that follow-up intervals are no greater than three months; consider immediate review of all patients whose last follow-up was more than three months ago.
Replace all devices in which high voltage therapy has been compromised.
Remind patients to contact their follow-up centre immediately, if they hear audible bleeping from their device, experience shock therapy and/or arrhythmias/resumption of symptoms which remain uncorrected by the device.
Report of instances of device failure to MHRA and Guidant.
Report explants to the National Pacing and ICD database (see contacts).
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock.
following reports of malfunction from clinicians outside the uk, guidant reviewed the design and manufacturing processes for the ventak prizm® 2 dr icd. the company identified the potential for loss of therapy in all units manufactured on or before 16 april 2002, when corrective measures were implemented.
on delivery of defibrillation therapy, the high voltage pulse may discharge (or arc) between the high voltage defibrillation output wire and a header component. the resulting discharge current may damage the icd electronics and cause any of the following:
loss of:
arrhythmia detection / therapy delivery
bradycardia pacing output
telemetry/ programming/ interrogation
a red warning screen indicating malfunction
a yellow warning screen indicating 'out of range' shocking impedance.
Action
See action points on page 3.
Ensure that follow-up intervals are no greater than three months; consider immediate review of all patients whose last follow-up was more than three months ago.
Replace all devices in which high voltage therapy has been compromised.
Remind patients to contact their follow-up centre immediately, if they hear audible bleeping from their device, experience shock therapy and/or arrhythmias/resumption of symptoms which remain uncorrected by the device.
Report all instances of device failure to MHRA and Guidant
Report explants to the National Pacing and ICD database (see contacts).
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Recall due to component failure resulting in potential loss of cardioversion, defibrillation and reduced device longevity.
guidant has informed mhra that all serial numbers of contak renewal® 4, contak renewal® 4 avt and renewal® rf devices are subject to a component failure that could result in limited available therapy, inappropriate therapy and a reduction in device longevity. as a precautionary measure, guidant has advised clinicians not to implant affected devices until further notice.
guidant has confirmed that the magnetic switch in these devices has the potential to stick in the closed position, resulting in the inhibition of the device's ability to treat ventricular or atrial tachyarrhythmias. bradycardia pacing remains unaffected. an audible tone, emitted from the device warns patients and/or clinicians of this condition. this component failure will increase the device's battery consumption and significantly reduce device longevity.
to date, guidant has distributed approximately 46,000 of these devices worldwide. there have been five reports, four confirmed and one unconfirmed, of component failure. the four incidents resulted in device replacement. in the uk, 670 devices have been distributed. there have been no reports of this component failure in the uk.
the default setting for these devices is 'enable magnet use on'. for devices already implanted, guidant recommends reprogramming the device to 'enable magnet use off'.
in 'enable magnet use off' mode:
bradycardia pacing and treatment of tachyarrhythmias will continue as programmed if the magnetic switch becomes stuck in the closed position
a magnet will no longer inhibit therapy
temporary suspension of tachyarrhythmia therapy can be performed with a programmer
the time between elective replacement indicators (eri) and end-of-life (eol) may be shortened.
Action
See actions on page 2.
Do not implant these devices until further notice from Guidant.
Immediately segregate all unimplanted devices and return them to Guidant in accordance with their instructions.
Review patients already implanted with these devices and verify device function using normal follow-up procedures.
Instruct patients to go to a hospital Accident and Emergency department immediately or to contact their clinician if they hear bleep tones from their device.
Consider programming device to 'Enable Magnet Use OFF'.
Ensure that follow-up intervals are no greater than three months (as per instructions for use).
Consider prophylactic explantation if the proposed programming option does not meet patient needs.
Report all instances of device failure to MHRA and Guidant.
Report explants to the National Pacing and ICD Database (see contacts).
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
St Jude Medical has informed the MHRA and all customers (Dear Doctor Letter dated 14 June 2005) that the above Atlas and Epic ICD models have the potential to experience either or both of the following problems:
Reason
(st jude medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (mda/2005/045).
Action
Verify that all St Jude Medical Model 3510 and 3510+ ICD programmers have been upgraded by St Jude Medical with software version 4.8.5 (or higher) by 27 July 2005.
Identify all patients implanted with the affected Epic or Atlas ICDs (serial number below 225000).
Ensure that identified patients are followed up (including interrogation of ICDs using a St Jude Medical upgraded programmer Model 3510 or 3510+):* by the end of September 2005, where the affected implanted devices are programmed at higher electrical current settings
by the end of December 2005, for all other affected implanted devices.
Report any instances of device failure to MHRA and St Jude Medical.
Report any explants to the National Pacing and ICD database.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Conmed and valleylab esus share the same type of footswitch connector but are wired differently. if the footswitches intended for one type of esu are used with the other, the esu will deliver 'cut' waveforms when the 'coagulate' footswitch is depressed, or 'coagulate' waveforms when the 'cut' footswitch is depressed.
Action
Theatre staff should check, before use, that footswitches operate cut and coagulate outputs correctly as advised in the manufacturer's instructions for use.
Maintenance staff should ensure that all footswitches are labeled for use with the appropriate ESU.
Staff should, as part of planned preventative maintenance, check that footswitches operate the correct cut and coagulate outputs.
Report to the MHRA and the manufacturer any instance where the labelling is not sufficient.
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
These, and some other, lancing devices are intended for self-use by one patient only, to take blood samples for self-monitoring. the use of softclix and softclix ii lancing devices by healthcare and care workers to take blood samples from multiple patients has been implicated in the transmission of hepatitis b between patients.
single patient lancing devices e.G. roche accu-chek softclix, softclix ii, softclix plus and multiclix are intended for self-use by one patient only, to take blood samples for self-monitoring. they are not intended for use by healthcare or care workers to obtain blood samples from multiple patients because there is a risk of cross infection and the transmission of blood borne viruses.
the mhra is aware that the inappropriate use of the softclix and softclix ii devices by healthcare and care workers to obtain blood samples from multiple patients has been implicated in recent outbreaks of hepatitis b in care homes in england, in which two patients have died.
Action
When testing multiple patients, healthcare and care workers should not use single patient lancing devices such as the Roche Accu-Chek Softclix, Softclix II, Softclix Plus or Multiclix lancing devices to obtain blood samples. When obtaining blood samples from more than one patient healthcare and care workers must ensure that the lancing device that they use is intended for this purpose.
When obtaining blood samples from patients, healthcare and care workers must ensure that they use
either
a lancing device that is intended for use by healthcare and care workers to obtain blood samples,
or
a disposable single-use lancing device (Please see MDA/2004/044 - Lancing devices for obtaining blood samples).
Healthcare and care workers should not use lancing devices intended for single patient use such as the Roche Accu-Chek Softclix, Softclix II, Softclix Plus or Multiclix lancing devices to obtain blood samples from multiple patients
Lancing devices such as the Accu-Chek Softclix Pro have been developed for use by healthcare and care workers to obtain blood samples from multiple patients. Multiple patient lancing devices and disposable single-use lancing devices are also available from other manufacturers.
Since August 2005 disposable single-use lancing devices have been available on prescription.
ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines.
Further information about SABS can be found at:
www.info.doh.gov.uk/sar/cmopatie.nsf
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Device may exhibit:intermittent or permanent loss of pacing output without warning
intermittent or permanent loss of telemetry
reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.Guidant has informed MHRA that all INSIGNIA and NEXUS implantable pacemakers may be subject to either one or two separate failure modes each having a different root cause.Affected devices will exhibit one or more of the following:intermittent or permanent loss of pacing output without warning
intermittent or permanent loss of telemetry
reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.Although there have been no reports of death as a result of these failure modes, serious health complications may result from the abnormal device behaviours associated with these failure modes.Details of the two failure modes are described below:
Device Family
Model Numbers
NEXUS Entra SSI
1325, 1326
NEXUS Entra DDD
1425, 1426
NEXUS Entra SR
1395, 1398
NEXUS Entra DR
1466, 1494, 1495
NEXUS Ultra SR
1390
NEXUS Ultra DR
1490, 1491
NEXUS Plus SR
1394
NEXUS Plus DR
1467, 1468
NEXUS AVT SSI
1328
NEXUS AVT VDD
1428
NEXUS AVT DDD
1432
NEXUS AVT SR
1392
NEXUS AVT DR
1492NB. Not all models are available in the UKA list of UK serial numbers for devices distributed on or before 12 March 2004, affected by the first failure mode can be found in Appendix 1.
Device Family
Model Numbers
INSIGNIA Entra SSI
0484, 0485
INSIGNIA Entra DDD
0985, 0986
INSIGNIA Entra SR
1195, 1198
INSIGNIA Entra DR
1294, 1295, 1296
INSIGNIA Ultra SR
1190
INSIGNIA Ultra DR
1290, 1291
INSIGNIA Plus SR
1194
INSIGNIA Plus DR
1297, 1298
INSIGNIA AVT SSI
482
INSIGNIA AVT VDD
882
INSIGNIA AVT DDD
982
INSIGNIA AVT SR
1192
INSIGNIA AVT DR
1292
Guidant has identified the potential for loss of pacing output and/or telemetry in a subset of INSIGNIA and NEXUS devices distributed prior to 12 March 2004.Guidant has confirmed that the root cause of this malfunction is the obstruction of a crystal timing component by loose material used in the component’s manufacturer. When this timing component is disrupted all device operations such as pacing, telemetry and magnet response may be prevented and the device can cease to function.To date, all device malfunctions associated with this failure mode have occurred within the first 22 months of implantation. Guidant believes that the likelihood of this malfunction occurring decreases with implant time, with a mean time to failure of seven months.Device failure is rare. As of November 2005, Guidant has received three reports of syncope and six reports of bradycardia requiring emergency hospitalisation. Engineering analysis by Guidant of an explanted device revealed that it had failed briefly but then resumed functioning with no detectable indication to the physician during routine follow-up.Guidant has received 37 confirmed reports of device malfunction associated with this failure mode: 7 devices exhibited a no output condition during the implant procedure; 21 devices exhibited a no output condition post implant procedure and 9 devices reverted to VVI pacing at 65 bpm.Out of 49,500 devices distributed prior to 12 March 2004, Guidant estimates that approximately 41,000 devices remain implanted, with approximately 2,200 implanted in the UK.Guidant predicts that up to 14 additional devices may malfunction worldwide over the remaining lifetime of the implanted products. Guidant has ensured corrective measures to address this issue have been implemented.MHRA has received two UK reports of syncope associated with these devices. Guidant issued information related to this problem to UK clinicians on 29 September 2005 (see Appendix 2).
Guidant has identified that all INSIGNIA and NEXUS devices may exhibit a no output condition during verification testing prior to implant or during implantation. No malfunctions have been observed after successful verification of the device at implant.As of November 2005, Guidant has received 17 confirmed reports of device malfunction at pre-implant testing or during implantation out of approximately 341,000 devices distributed worldwide. In one (non-UK) report a pacemaker dependent patient experienced syncope and was resuscitated following cardiac arrest. This was associated with loss of pacing output during an elective pacemaker replacement procedure.There have been no reports of device malfunction at pre-implant testing or during implantation in the UK to date. The number of potentially affected devices in the UK is approximately 11,000.Guidant has yet to determine a specific root cause for this failure mode and continues to investigate this failure.Guidant will issue further advice when more information is available.Guidant also issued information related to this problem on 29 September 2005 (see Appendix 2).MHRA will continue to monitor both these situations.
Reason
(guidant) device may have intermittent or permanent loss of pacing output without warning, intermittent permanent loss of telemetry, reversion to ventricular inhibited pacing (vvi), and/or reset warning message upon interrogation. (mda/2005/067).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Recall due to component failure.The information provided in this alert is an update to the information provided in MDA/2005/067 issued on 08 December 2005 which advised of two failure modes, which were described as: ‘First failure mode’ and ‘Second failure mode’.This Alert provides updated information concerning the second failure mode. There is no change to previous information provided about the first failure mode.Guidant has initiated a world-wide recall of certain INSIGNIA and NEXUS implantable pacemakers and has now identified why a subset of these devices exhibits no output conditions during verification testing prior to implant or during the implantation procedure (the second failure mode).Guidant has identified that these devices can malfunction if they incorporate a defective crystal timing component manufactured by one of two suppliers.Guidant has determined that a problem with the manufacturing process of this component can, in rare instances, result in a microscopic particle of quartz crystal entering the internal cavity of the crystal timing component. This particle can electrostatically attach to the inner surface of the crystal casing and subsequently detach through normal handling or during transit. The loose particle can then adhere to the crystal tuning mechanism causing crystal malfunction, and consequential malfunction of the master oscillator circuit that controls all pacemaker timing functions. Malfunction of the master oscillator will result in intermittent/permanent loss of pacing or telemetry.Although all models of INSIGNIA and NEXUS implantable pacemakers are affected, this recall is restricted to those devices that have been assembled using defective crystal timing components (see list of affected serial numbers distributed in the UK on our website).To date, Guidant has received 17 confirmed reports of device malfunction out of 257,000 devices distributed worldwide. These all occurred at pre-implant testing or during the implantation procedure.There have been no reports of device malfunction in the UK at pre-implant testing or during the implantation procedure. The number of potentially affected devices in the UK is approximately 8,000.Since all failures have occurred before or during the implantation procedure neither Guidant nor MHRA advise additional follow-up for successfully implanted devices at this time.Guidant also issued updated information related to this problem to UK clinicians on 16 December 2005 (see Appendix 1).MHRA will continue to monitor the situation and will consider issuing further advice.
Reason
(guidant) component failure. (mda/2005/070).
Action
Do not implant affected INSIGNIA or NEXUS implantable pacemakers Review stocks of INSIGNIA and NEXUS implantable pacemakers and identify those included in the recall.
Immediately quarantine affected devices and return them to Guidant in accordance with their instructions.
Report all instances of devices failure to MHRA and Guidant.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Failure of interconnecting wires within the pacemaker may cause:loss of pacing output from atrial and/or ventricular ports
premature battery depletion
intermittent or total loss of telemetry
undersensing
high lead impedance values
loss of rate response
device reset to manufacturer’s default settingsMedtronic has advised MHRA that some Sigma® pacemakers from the above model ranges may be subject to failures which could result in any of the behaviours listed on page 1. Medtronic issued letters to clinicians about this issue in November 2005 (See Appendices 1 and 2).Medtronic’s analyses of 19 returned Sigma® pacemakers has identified a failure mode where separation of interconnecting wires between certain electronic components, can seriously affect the performance of the device.Analysis has identified that the wire separation is associated with the use of an incorrect cleaning solvent during circuit board manufacturing that contained an antioxidant. The solvent, which was only used for a limited manufacturing period, resulted in surface contamination of electrical connection areas prior to wire bond connection. Extensive testing and analysis by Medtronic has now confirmed that use of this cleaning solvent can lead to a reduction in strength of the wire bond connections and these connections may separate over time. No mean time to failure has been established for this failure mode however there have been no failures less than 17 months post implant.There is no provocative testing that can be performed to identify when any of the affected devices may fail.Failure rates are currently low at approximately 0.05%. To date 19 Sigma® failures have been confirmed where wire bond connections have separated. Medtronic estimate that approximately 28,000 devices remain implanted worldwide. In the UK 1 failure by this mode has been confirmed to date out of an estimated 1700 devices that remain implanted. The UK failure occurred at implant duration of 36 months with the patient presenting with shortness of breath. Subsequent clinical checking confirmed no pacing output or telemetry.Medtronic have received no reports of serious injuries or deaths due to this problem.Affected Sigma® pacemakers may be identified through accessing the Medtronic website http://SigmaSNList.medtronic.com
Reason
(medtronic) failure of interconnecting wires may cause loss of pacing output from atrial and or ventricular ports, premature depletion of battery, intermittent or total loss of telemetry, undersensing, high lead impedance values, loss of rate response, device reset to manufacturer's default settings. (mda/2005/072).
Action
Identify and return to Medtronic all un-implanted devices that are potentially affected (under ‘Download Documents’ below)
Identify all patients that have affected pacemakers and where last follow-up was longer than six months, arrange for pacemaker follow-up as soon as possible, giving priority to pacemaker dependant patients.
At follow-up confirm that the device is performing as expected. Abnormal device behaviours may include:
intermittent or total loss of pacing output in either or both of the atrial/ventricular ports
intermittent or total loss of telemetry
unanticipated premature battery depletion
unexplained increases in lead impedance(s) in unipolar or bipolar mode
undersensing
loss of rate response function (where applicable and programmed on)
power on reset - return to manufacturer’s default settings
Advise patients to contact their follow-up clinic immediately if they experience return of symptoms (e.g. syncope / light-headedness or shortness of breath).
Consider elective device replacement if any of the above device behaviours are detected, especially for pacemaker dependant patients giving consideration to each patient’s medical history, degree of pacemaker dependency and the relative risks of an invasive procedure.
Consider scheduling subsequent pacemaker follow-up at intervals no longer than six months, for all potentially affected pacemakers, to monitor for signs of device degradation.
Report all incidents of device failure to the MHRA and Medtronic.
Report explants to the National Pacing and ICD Database (see Contacts).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
The povidone-iodine contained in the disconnect caps of these peritoneal dialysis sets has the potential to be a contributing factor to thyroid changes such as hypothyroidism. Patients more likely to be affected are infants and children with smaller peritoneal fill volumes, where higher dialysate concentrations of iodine can result.
Reason
(baxter healthcare ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (mda/2006/022).
Action
The thyroid function should be monitored in patients with small peritoneal dialysate fill volumes, typically infants and children. In order to minimise iodine exposure, the contents of the peritoneal cavity should be drained to the drain receptacle prior to the initiation of the next fill cycle whenever clinically possible.Users should be aware of the advice in Baxter’s Safety Alert (see appendix in pdf).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Recall due to component failure.
guidant has informed mhra that a sub-set of the implantable pacemaker/defibrillators listed above may suffer degradation of a high-stability low-voltage capacitor leading to device malfunction or premature battery depletion. prevalence of device malfunction in the future and the mean time to failure have not yet been established.
contaminated material used in the manufacturing process of a low-voltage capacitor for these devices can cause a leakage of current resulting in appropriate device behaviour or premature battery depletion. one or two of these capacitors are used in each device depending on device design.
guidant has identified the actual failure mechanism and corrective action has now been implemented. based on experience of reported incidents, capacitor failure is likely to occur in the early part of the device's life period; however it is not possible to estimate when capacitor failure will occur. analysis is ongoing to improve understanding of the prevalence and the time to failure of these devices.
to date guidant has confirmed 5 reports of device malfunction associated with this issue out of approximately 27,200 implanted devices worldwide. one device malfunction was discovered at the time of implant; in the other four reports the devices required replacement.
to date, approximately 1,500 potentially affected devices have been distributed in the uk and the republic of ireland. guidant believe that the majority of these have already been implanted. approximately 49,800 affected devices have been distributed worldwide.
guidant issued a letter with patient management recommendations to clinicians in the uk on 28/06/06 (see appendix 1 in pdf).
Action
See actions on Page 3.
Do not implant affected devices. (See list of affected serial numbers distributed in the UK and the Republic of Ireland on our website)
Immediately quarantine all affected devices and return them to Guidant in accordance with their instructions.
Identify patients implanted with affected devices and review them as soon as possible, giving priority to those who are device dependent or who have not been followed up within the last three months.
During follow-up, verify device function using normal programmer follow-up procedures, checking for:
no telemetry/pacing output
ERI or EOL indications
suspected premature battery depletion
For specific model families, possible device malfunction behaviours may include (but are not limited to):
Incomplete or missing PRM daily measurements
Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings
Fault code 11 upon interrogation
Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings
Battery voltage less than 3.10 V within six months of implant
Abnormal P&R wave measurements
Abnormal signals and markers on real-time or stored electrogram, which may result in inappropriate sensing and therapy
*Not distributed within Europe
Consult Guidant if you identify any of the above.
Consider the risks and benefits of elective device replacement in device dependant patients if any of the above is confirmed.
Schedule future patient follow-ups at intervals of no longer than three months for early detection of device failure.
Instruct patient to contact their follow-up centre immediately or go to a hospital Accident and Emergency department if they experience a slow heart rate, syncope/light-headedness, inappropriate therapy or new or increased symptoms of heart failure.
Report all instances of device failure to MHRA and Guidant.
Report explants to the National Pacing and ICD Database (see Contacts on page 4).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Risk of anaesthetic overdose.
the mhra is aware of an adverse incident that occurred at the beginning of 2005 during the use of an anaconda. it is believed that the adverse event was caused by a combination of user error and inconsistencies in the instructions for use. sedana medical have taken over as the manufacturer of the anaconda and corrected these inconsistencies. the current version of the instructions for use is ifu 7 691 300-r001, published in july 2005 (available at
www.Sedanamedical.Com
(external link)).
sedana medical is implementing changes to the design of the system to eliminate the luer connection between the syringe and the anaconda and is making additional changes to the instructions for use. sedana medical estimates that these changes will be introduced on new products at the end of 2006.
Action
Check that there are procedures in place to ensure that the AnaConDa device is only used:
according to the current version number of the instructions for use (At the time of publishing this is version number 9 691 300-R001, issued in July 2005)
by clinicians specifically trained in the use of anaesthetic drugs
with the correct level of monitoring and respiratory support, as recommended by the AAGBI (Recommendations for standards of monitoring during anaesthesia and recovery, 3rd edition, 2000).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
Potential for inaccurate display of:
battery voltage
expected battery longevity
elective replacement indicator (eri) status
at initial programmer interrogation.
st jude medical has advised mhra that a programmer software anomaly can occur when the above programmers and pacemakers are used together. the manufacturer notified their uk customers of this issue in a letter dated 12 october 2006 (see appendix).
the problem, which has only affected 53 out of approximately 199,100 pacemakers, results in the display of inaccurate battery voltage, expected battery longevity, and eri status. the anomaly does not affect the pacemaker's actual battery voltage, longevity or functionality. display of inaccurate data
only occurs at initial programmer interrogation.
correct battery voltage measurements and longevity status etc. will only be displayed when a
manual measured data reading is performed.
the anomaly is the result of a software interaction where a memory location within the pacemaker changes state. when this occurs, the data read on initial interrogation (from the pacemaker's memory) is not up to date. this affects the calculations for battery voltage, remaining longevity, eri status and magnet rate and therefore the displayed information is incorrect. in addition, as pacemakers approach the elective replacement time, this could result in the reporting of inappropriately high battery voltage and remaining longevity and could result in a delay in indicating eri status.
to correct this problem, st jude medical has developed a software upgrade which, when installed on the programmer, will automatically correct an affected pacemaker memory location and ensure accurate battery status information is displayed. st jude medical advises that this will take place on first pacemaker interrogation following programmer software upgrade and will not extend the time needed for the appointment. st jude medical plans to release the upgraded software in december 2006 and anticipates that all potentially affected programmers in the uk will receive the software upgrade by the end of january 2007.
st jude medical has already communicated this information to all uk hospitals that have received potentially affected pacemakers and programmers. neither st jude medical nor mhra have received any reports of adverse clinical events associated with this issue.
Action
See detailed actions for patient management on page 3.
For patients with pacemakers within two years of the longevity published in the pacemaker manual, perform a patient follow-up as soon as practically possible, giving priority to pacing dependent patients.
For patients with pacemakers not within two years of published longevity, perform follow-up at the scheduled intervals.
If you already routinely perform a manual measured data reading during follow-up, there is no need for any action.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
The mhra has received reports of:
inadequate ventilation in non-intubated patients
thoracic cage and lung damage
raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply.
Action
Ensure that all users of this device are aware of the ventilation update to the instructions for use from Jolife AB, appended to this Alert. This now states that when used in non-intubated patients the device can be safely stopped to allow intermittent manual ventilation.
Ensure the device is placed correctly, according to its instructions for use (IFU).
If the device is powered by oxygen and used in confined spaces (e.g. ambulances) ensure there is adequate ventilation. In ambulances always run the ventilation at the highest capacity and do not recirculate the air.
If the device is powered by oxygen always ensure there is an adequate oxygen supply for both the Lucas device and the patient’s respiratory requirements.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Delay in delivery of therapy during device middle-of-life phase due to temporarily extended charge time limits.
Transition to device end of life (EOL) without prior observation of elective replacement indication (ERI) even though battery capacity remains available.The MHRA has received 31 reports of early explants from four of the above device models (1870, 1871, 1872, A135) during the middle-of-life (MOL) phase. Replacement has been due to observation of premature elective replacement / end of life indicators (ERI/EOL), caused by long capacitor charge times. The MHRA has also become aware of confusion about ERI/EOL indicators throughout implant duration.Incident reports have included devices displaying:extended charge times where no replacement / end of life indicators have been observed
ERI where charge times have extended beyond 26 seconds giving rise to potentially inappropriate therapy delay for some patients
EOL indicators with charge times in excess of 30 seconds without ERI being observed in the first instance.Boston Scientific ICDs / CRTDs are designed to regularly monitor both battery voltage and capacitor charge time, and flag ERI when specified limits are exceeded. Charge time ERI is flagged whenever two charges (capacitor reform or therapeutic shock) occur within a 24hr period in which both exceed the specified limit.Increase in charge time (due to a rise in battery impedance) is an expected behaviour of ICDs that have lithium-silver-vanadium-oxide batteries. However, early batteries used in some of the above models have a tendency to exhibit a more exaggerated increase in battery impedance during the MOL phase, due to a battery manufacturing anomaly.Boston Scientific has confirmed that the above models have been programmed with temporarily extended ERI charge time limits during the MOL phase (compared to unaffected models). This is to prevent premature tripping of ERI due to the battery impedance characteristic.In January 2007, Boston Scientific issued a product update about this issue via their website. The company issued a more detailed and informative product update about this problem in March 2007.The MHRA is issuing this Medical Device Alert to ensure that all UK clinicians who implant these devices, or manage patients already implanted with these devices, are aware of Boston Scientific’s communication and can therefore consider the clinical implications of long charge times that may be inappropriate for some patients.
Reason
(boston scientific ltd.) patients may experience extended charge times in the middle-of-life phase of the device, which could lead to a delay in shock delivery; also replacement and end of life indicators may display earlier than expected. (mda/2007/023).
Action
Identify patients implanted with these devices, asses clinical risks associated with the above device problems, and follow the actions on page 2.Be aware of:
extended capacitor charge times during device MOL phase, as documented in the most recent Boston Scientific product update (see the MHRA’s website for March 2007 issue)
the higher prevalence of long charge times in earlier manufactured devices (see Appendix 2 below)
the potential for earlier manufactured devices to pass from ERI to EOL in less than three months.
At the next scheduled follow-up, review capacitor charge time history and evaluate the appropriateness of charge time according to patient condition and device dependency, giving priority to those who have not been followed up within the last three months (see Appendix 1 below).
Consider the risks (infection etc) and benefits of elective device replacement where capacitor charge time is judged to be inappropriate for an individual patient.
Consider scheduling future patient follow-ups at three monthly intervals – where the device is around MOL, to increase the likelihood of detecting longer charge times, early ERI and/or EOL as appropriate.
Consider programming the ‘Beep When ERI is Reached’ feature to ‘ON’ (default) for all affected patients.
Remind patients to contact their follow-up centre immediately if they hear beeping from their device and/or experience arrhythmias/resumption of symptoms that remain uncorrected by the device.
Consult the Boston Scientific website for future related product updates.
Report all instances of device failure to the MHRA and Boston Scientific.
Report explants to the National Pacing and ICD Database (see contacts on page 3).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Extra notes in the data
Reason
The outer sheath and light guide tube of flexible endoscopes may be damaged by prolonged exposure to ultraviolet (uv) light used in these endoscope storage and drying cabinets.
afos (nse) ltd has informed the mhra that some endoscope storage and drying cabinets have been fitted with a non-standard programme that allows the uv light to be switched on for eight hours a day instead of the expected 15 minutes every six hours. the mhra has received a report of significant deterioration to a flexible endoscope that was stored in an afos cabinet fitted with an incorrect programme.
this type of damage to the outer sheath of the flexible endoscope insertion tube and light guide tube may:
cause trauma to the patient;
affect the functionality of the scope;
allow ingress of fluids into the endoscope;
inhibit effective decontamination of the endoscope by allowing micro-organisms to be retained in the damaged area of the endoscope;
reduce the number of endoscopes available for use in the unit whilst the affected endoscope is being repaired.
Action
Check all flexible endoscopes that have been stored in AFOS endoscope storage facilities for damage.
If the endoscope is damaged do not use it until it has been repaired.
Contact AFOS to ensure that the endoscope storage and drying cabinet has the correct programme for UV light exposure.
Do not use the storage and drying cabinet if it has the incorrect programme fitted.
If no other suitable storage and drying cabinet is available carry out a risk assessment for the continued use of these cabinets for storing endoscopes.
Be aware of MHRA advice given in MDA/2007/034.