German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st. jude medical merlin@home transmitter
the united states food and drug administration (fda) has issued a medical device safety alert concerning merlin@home transmitter, manufactured by st. jude medical.
the fda is providing information and recommendations regarding st. jude medical's radio frequency (rf)-enabled implantable cardiac devices and merlin@home transmitter to reduce the risk of patient harm due to cybersecurity vulnerabilities.
many medical devices—including st. jude medical's implantable cardiac devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. as medical devices become increasingly interconnected via the internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.
to improve patient safety, the manufacturer has developed and validated a software patch for the merlin@home transmitter that addresses and reduces the risk of specific cybersecurity vulnerabilities. the fda has reviewed st. jude medical's software patch to ensure that it addresses the greatest risks posed by these cybersecurity vulnerabilities, and reduces the risk of exploitation and subsequent patient harm. the fda conducted an assessment of the benefits and risks of using the merlin@home transmitter, and has determined that the health benefits to patients from continued use of the device outweigh the cybersecurity risks.
the fda urges health care providers to:
continue to conduct in-office follow-up, per normal routine, with patients who have an implantable cardiac device that is monitored using the merlin@home transmitter.
remind patients to keep their merlin@home transmitter connected as this will ensure that patients' devices receive the necessary patches and updates.
the fda urges patients and caregivers to:
follow the labeling instructions provided with their merlin@home transmitter. keeping their monitor connected as directed will ensure their monitor receives necessary updates and patches. keep in mind that although all connected medical devices, including this one, carry certain risks, the fda has determined that the benefits to patients from continued use of the device outweigh the risks.
seek immediate medical attention if they have symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath.
for details, please refer to the fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm535979.Htm
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm535843.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 10 january 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st jude medical fortify st implantable cardioverter defibrillator
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning fortify st implantable cardioverter defibrillator (icd) models [cd1235-40, cd1235-40q, cd2235-40 and cd2235-40q], manufactured by st jude medical.
the merlin pcs programmer software model 3330 versions 14.2.2, 16.2.1 and 17.2.1.1 provide new features for st. jude medical pacemakers, icds and crt-ds, including an option to enhance the st diagnostic features in st. jude medical fortify st icd models cd1235-40, cd1235-40q, cd2235-40 and cd2235-40q via a device software upgrade. during a device software upgrade, implanted devices are temporarily placed into the back-up pacing (bvvi) and back-up defibrillation only (bdfo) mode. the back-up mode parameter settings will be in effect for the two minute upgrade process. once the upgrade successfully completes, the device will revert to the previously programmed parameter settings. the safety alert is being provided to ensure that the operation of these devices during backup operation is clearly understood. depending on the individual patient, this temporary change in parameter values could make the device susceptible to over-sensing and potentially deliver high voltage therapy during the upgrade procedure.
in order to prevent the potential for inappropriate therapy during the software upgrade process, the manufacturer advises users to consider programming the “tachy therapy enabled/disabled” function to disabled prior to proceeding with the software upgrade. it is imperative to re-interrogate the device and program the “tachy therapy enabled/disabled” function to enabled after the upgrade has been successfully completed. as with any device evaluation and programming, ecg monitoring and availability of back up external defibrillation equipment is recommended during the entire software upgrade process.
according to the local supplier, the affected products were distributed in hong kong.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con261823
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 april 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st jude medical amplatzer atrial septal occluder
the united states food and drug administration (fda) has issued a medical device safety alert concerning amplatzer atrial septal occluder (aso), manufactured by st jude medical.
the fda is alerting health care providers and patients that in very rare instances, tissue surrounding the amplatzer aso can break down (erode) and result in life-threatening emergencies that require immediate surgery. according to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the amplatzer aso. as of 31 march 2013, there have been 234,103 amplatzer aso devices sold worldwide.
according to the fda, tissue erosion caused by the amplatzer aso is rare, but can be life-threatening. between 2002 and 2011, the fda received more than 100 reports of erosions associated with the st. jude amplatzer aso. during the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device.
the device rubbing against the wall of the heart can erode the tissue and create a hole. it can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. this scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade). if too much blood builds up in this sac, the heart will not be able to work properly.
immediate open heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. tissue erosion can also cause fistulas - abnormal scar tissue that connects parts of the heart that were not previously connected. fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure.
the fda does not recommend device removal for patients who have the amplatzer aso unless physicians determine it is appropriate for their particular patient(s). the risks associated with device removal surgery may be equal to or greater than the risk of erosion. in addition, the fda is requiring st. jude to conduct a study of patients who have been recently implanted with the device so as to better understand how erosion impacts the performance of the amplatzer aso and assess potential risk factors related to the occurrence of erosion.
for details, please visit the following fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm371202.Htm
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm371145.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st. jude medical implantable devices- fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra
medical device manufacturer, st jude medical, has issued a medical device safety alert concerning its implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) manufactured before may 2015. the affected models are fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra.
according to the manufacturer, among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. forty-six exhibited visible clusters bridging the cathode and anode causing shorting. lithium cluster formation is a known phenomenon with this type of battery.
the manufacturer is contacting physicians to provide details regarding risk and patient management recommendations because premature battery depletion has been observed to occur within days. there have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion.
high voltage devices (icds and crt-ds) that utilize lithium-based battery chemistries are subject to lithium cluster formation during high voltage charging. depending on their location, lithium clusters may cause a short circuit that can lead to premature battery depletion. the manufacturer’s investigation indicates that if a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy.
premature battery depletion can be identified by physicians through home monitoring or in person visits showing elective replacement indicator (eri) or more advanced battery depletion. patients may become aware when their device reaches eri because they may feel a vibratory patient notifier alert. patients who cannot feel the vibratory alert may not know their device has reached eri. therefore, the manufacturer has provided recommendations below that include confirming patients can feel and recognize vibratory alerts and reaffirming the availability and usage of home monitoring to avoid or minimize time without device therapy for bradycardia and tachycardia events.
the manufacturer provided physicians with the following patient management recommendations:
do not implant unused affected devices.
conduct patient follow-up per standard practice.
prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion due to lithium cluster induced shorts.
in the event of an eri indicator in these devices, immediate device change is recommended. at this time there is no factor, method or test to identify devices with this form of premature battery depletion approaching eri or to accurately predict remaining battery life once eri appears.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for further patient management recommendations and other necessary actions.
posted on 11 october 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st. jude medical ellipse vr/dr implantable cardioverter defibrillators
the australia therapeutic goods administration (tga) posted a medical device safety alert concerning ellipse vr/dr implantable cardioverter defibrillators (icds) manufactured by st. jude medical. the affected models are cd1277 (-36 and -36q), cd1377 (-36, -36q, -36c and -36qc), cd2277 (-36 and -36q) and cd2377 (-36, -36q, -36c and -36qc). icds with serial numbers beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.
the manufacturer has received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value.
this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock.
according to the manufacturer, there have been no reported cases of an ellipse device failing to deliver high voltage therapy to a patient when needed.
the manufacturer is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with the affected devices.
furthermore, the manufacturer advises customers that the affected stock will be retrieved and replaced by new ellipse icds with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole.
for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00905-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 20 august 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st. jude medical riata and riata st silicone endocardial leads
the united states food and drug administration (fda) has issued a press release and safety notices concerning riata and riata st silicone endocardial leads manufactured by st. jude medical inc. riata and riata st leads connect an implantable cardioverter defibrillator (icd) to the heart in order to monitor heart rhythms. icd can detect life threatening heart rhythms and deliver an electrical shock from the icd through the lead to the heart.
in december 2010, st. jude medical reported that the outer insulation material, silicone rubber, had been observed to be vulnerable to abrasion and might lead to premature insulation failure that could impact the lead's ability to function properly. lead insulation failure may cause the icd lead to malfunction. icd lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death. st. jude had phased-out all models of riata and riata st silicone leads in december, 2010.
according to the fda, the increase in frequency of reported riata insulation failures began approximately four years after implantation. however, there is currently not enough information to determine how often and how soon the riata insulation fails and the risk factors of insulation failure or externalization of the electrical conductors. the fda issued a press release and safety notices to provide information and recommendations regarding safety concerns with the products.
recommendations for healthcare professionals:
the affected patients should be monitored closely and assessed for any electrical abnormalities.
physicians should image riata and riata st leads implanted in patients to assess for externalization or other visible insulation abnormalities, if it is not contraindicated.
physicians should consider remote monitoring for patients to better detect electrical abnormalities.
st. jude medical recommends reprogramming the device to increase the chance for detection of a lead abnormality. the patient alert and remote monitoring alerts should also be turned on.
the fda, st. jude medical and the heart rhythm society do not recommend routine removal of any leads due to the risks of explantation surgery. physicians should only consider replacing the lead if there is evidence of insulation failure in imaging and if there is abnormal electrical function.
recommendations for patients:
patients should contact their cardiac physician to determine if they have the affected leads.
patients are advised to discuss with the physicians to find out the best management plan they should adopt.
the fda is requiring st. jude medical to conduct three-year post-market surveillance studies to address concerns related to premature insulation failure and to address important questions related to follow-up of affected patients.
according to the local supplier, the affected models have been distributed in hong kong. for details, please refer to fda website:
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/
ucm314930.Htm
http://www.Fda.Gov/newsevents/newsroom/pressannouncements/
ucm315684.Htm
http://www.Fda.Gov/safety/medwatch/safetyinformation/
safetyalertsforhumanmedicalproducts/ucm315718.Htm
patients who have icd with riata and riata st leads, please contact their physician for necessary actions. for healthcare professionals, please contact your supplier for information.
posted on 17 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Safety information regarding st. jude medical implantable cardioverter defibrillators
10 october 2005
the department of health was notified today by the manufacturer of several older generation implantable cardioverter defibrillators that some of its products may be affected by cosmic rays and may not function properly.
according to st. jude medical (hong kong) ltd., the affected models are:
photon dr (model v-230hv) (certain serial numbers)
photon micro vr/dr (models v-194/v-232)
atlas vr/dr (models v-199/v-240)
no serious patient injury or death has been reported so far.
there are totally 34 patients implanted with the affected devices through the public hospitals in hong kong. the supplier has advised the hospital authority of this matter. all the affected patients will be informed by their doctors for follow up actions shortly.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Software defect causes malfunction in implantable cardioverter-defibrillator the department of health (dh) today (may 6) received notification from st. jude medical (hong kong) ltd., a local branch of a multi-national company, about a software problem in its convert+ model v-195 implantable cardioverter-defibrillator (icd).
the model, if programmed by a merlin pcs programmer running version 7.2.1, version 8.2.1 or version 10.2.0 software, may not deliver therapy under certain circumstances. the defect can be corrected. st jude medical recommends doctors who have programmed a patient's device with any of the affected software versions should schedule a follow-up visit to perform the correction recommended by it.
according to st. jude medical (hong kong) ltd., one patient has been implanted with this model of icd in hong kong. however, the implanted device has not been programmed with the affected software version. this model of icd ceased to be sold by the company in hong kong since mid-2007.
no patient injury or death has been reported worldwide.
patients may call st. jude medical (hong kong) ltd. at 9682 0488 for further details.
a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell.
meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with st. jude medical (hong kong) ltd. on further development, if any.
end/thursday, may 6, 2010.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Field safety notice: st. jude medical quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t]
medical device manufacturer, st. jude medical, initiated a field safety corrective action concerning the quicksite® and quickflex® left ventricular crt leads [models 1056t, 1058t, 1156t and 1158t].
according to the manufacturer, the affected devices are designed for use in combination with a compatible pulse generator to provide long-term stimulation and sensing of the left ventricle via the great cardiac vein or one of its tributaries.
the manufacturer had found 39 confirmed cases of externalized conductor. it was estimated that 3-4% of quicksite® and quickflex® leads may exhibit the anomaly. there were no reports of death or serious injury associated with externalized conductor.
according to the manufacturer, if externalization of the cable conductor were to occur, the etfe coating on the cables is designed to provide adequate dielectric strength for the lead to continue to function normally without the silicone covering. the system also provides for multiple alternative pacing configurations that can be programmed, if needed. although no electrical dysfunction attributable to these external conductors has been observed to date, in the case that all of these redundancies were to fail, the inability of the lv crt lead to pace could affect biventricular pacing and result in exacerbation of heart failure.
the manufacturer recommended physicians to continue to monitor their patient’s implanted system at regularly scheduled intervals with attention paid to diagnostic information related to lv pacing performance, in particular lv lead impedance and capture thresholds. in addition, programming of alerts that monitor lead impedance changes outside of the nominal range and enabling the patient notifier should be considered.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st.Jude medical merlin@home transmitter
the health canada posted a medical device recall notice concerning merlin@home transmitter, manufactured by st. jude medical, cardiac rhythm management system. the affected model number is ex1150.
according to the manufacturer, there is potential for intermittent communication difficulties with these merlin@home transmitters due to an anomaly with a microcontroller chip in the transmitter. if the anomaly occurs, the patient's merlin@home transmitter will not be able to send data to the merlin.Net database. however, implanted device function is not affected.
for details, please refer to health canada website
http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 27 jun 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: boston scientific pacemakers and cardiac resynchronization therapy pacemakers - minute ventilation signal oversensing
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its cardiac resynchronization therapy pacemakers (crt-ps).
the affected crt devices are identified as the following:-
valitude crt-p [models: u125 and u128]
accolade pacemakers [models: l300, l301, l310, l311, l321, l331]
essentio pacemakers [models: l100, l101, l110, l111, l121, l131]
visionist crt-p [models: u225, u226 and u228]
proponent pacemakers [models: l200, l201, l209, l210, l211, l221, l231]
altrua 2 pacemakers [models: s701, s702, s722]
the manufacturer has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with its certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer’s pacing lead system, but the manufacturer has determined it to be more likely for the affected pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
according to the manufacturer, its pacemakers can be used for rightrate (rate adaptive pacing), respiratory rate trend, or ap scan. when the ra/rv pacing leads and lead terminal connections are operating as intended, the mv sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (egms). however, intermittency related to the lead or pacemaker-lead connection has the potential to create a transient high impedance condition. a high impedance condition may subsequently alter the mv sensor signal such that it becomes visible on egms and potentially subject to oversensing on the ra or rv channels.
the manufacturer is actively developing a software update designed to automatically detect and resolve this mv sensor signal oversensing behavior.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 december 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Software problem found in programming devices for implantable pacemakers
the department of health received notification from a medical device manufacturing company about a software problem in two programming devices used by doctors for checking the battery level of pacemakers.
the programming devices concerned, produced by st. jude medical inc., are aps iii model 3500/3510 programming devices (software versions 6.1.1 and earlier) and merlin pcs model 3650 programming devices (software versions 4.1.1 and earlier). they are specially designed and made to measure the battery level of the following three pacemaker models manufactured by the same company -
identity sr model 5172
identity dr model 5370
identity xl dr model 5376
a spokesman for dh said the software problem may lead to incorrect reporting of battery voltage, expected battery lifespan of the pacemakers and early replacement indicator in the devices. the details can be found at the corporate website of st. jude medical, inc. at www.Sjm.Com .
dh has alerted the hospital authority, private hospitals and other relevant medical professional organisations of this safety information.
no patient injury or death has been reported so far.
the spokesman said patients shall call the hotlines of st. jude medical ( hong kong ) ltd at 2996 7688 from 9 am to 6 pm from monday to friday for enquiries. they can call 9666 4545 or 9777 0097 outside office hours.
he reminded patients with these implanted pacemakers to attend scheduled regular check-ups arranged with their doctors. if they have any symptoms of heart disease, they should seek medical attention immediately.
end/thursday, october 19, 2006
nnnn.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: st. jude medical accent sr and accent dr pacemakers
the medicines and healthcare products regulatory agency(mhra), united kingdom posted a field safety notice concerning accent sr and accent dr pacemakers, manufactured by st. jude medical.
the manufacturer has identified that a subset of accent sr single chamber model pm1110 and accent dr dual chamber model pm2112 pacemakers will not provide a change in sensor driven (rate responsive) pacing rates in response to patient physical activity due to an incorrect software setting. in devices programmed to a rate-responsive mode, the pacemaker will function in a basic programmed mode and will not provide a sensor driven rate increase when the patient is physically active. all other programmed parameters, features and functions operate as designed, e.G. an accent dr device programmed to dddr will appropriately track atrial activity and properly function in the ddd mode.
according to the manufacturer, recall of the unimplanted products is on-going. the manufacturer advises healthcare professionals to:
identify affected patient.
review affected patient’s clinical indications for pacing and determine the clinical need for rate responsive, sensor driven pacing.
in the event that a patient requires rate responsive sensor driven activity pacing and exhibits clinical symptoms due to the lack of increased pacing rates with exercise, contact local sales representative or technical support.
continue to follow patients on their standard follow-up schedule.
furthermore, according to the manufacturer, a non-invasive programmer software solution will be developed and once it is available, the sensor anomaly can be automatically corrected at follow up by a simple interrogation of the pacemaker. follow up of patients exhibiting clinical symptoms due to the lack of increased pacing rates with exercise should be prioritized.
according to local supplier, the affected products were not distributed in hong kong.
for details, please refer to the following mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/
con213146
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 11 december 2012.