"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Extra notes in the data
Reason
Four communications to help identify and manage issues that may impact the safe delivery of therapy using the synchromed® ii and synchromed el implantable drug pumps.
Action
The IMB recommends that:
1. Relevant personnel in your organisation are made aware of these potential issues.
2. The device and patient management advice outlined in the Medtronic Communications is followed.
3. Unused sutureless connector catheters with a used by date prior to 25th August 2014 should be returned to Medtronic.
4. This IMB Safety Notice and the attached Field Safety Notices are passed on to any organisation or end user where the potentially affected devices have been transferred.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Extra notes in the data
Reason
Medtronic has detected an upward shift in reports of occurrence for overinfusion associated with the synchromed® ii implantable pump. overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump.
Action
The IMB recommends that:
1. Relevant personnel in your organisation are made aware of these potential issues.
2. The device and patient management advice outlined in the Medtronic Communications is considered and followed as appropriate.
3. This IMB Safety Notice and the attached FSN are passed on to any organisation or end user where the potentially affected devices have been transferred.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electronic circuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and leads to a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms.
Action
Through the 'Hazard Alert' letter, Medtronic is advising clinicians regarding ongoing patient management recommendations. Medtronic does not recommend prophylactic replacement of SynchroMed II or SynchroMed EL pumps due to the estimated low occurrence rate, the presence of pump alarms, and the risks associated with replacement surgery. However, appropriate consideration should be given to individual patient needs.
If repeated short duration motor stalls, Low Battery Resets (with or without Safe State), or a premature Elective Replacement Indicator occur, replacement surgery should be scheduled for therapy continuation. Alternative medical management should be considered if appropriate.
For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The clinician refill reference card for synchromed implantable infusion systems that was originally distributed with the january 2011 safety alert (tga ref.: rc-2010-rn-01266-3) related to pocket fills has been updated to align with new product labelling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient’s subcutaneous tissue, which includes the pump pocket, instead of the pump which can lead to life-threatening symptoms, serious patient injury, or death due to overdose or underdose.
Action
The main title of the Clinician Refill Reference Card has been updated to read Critical Actions in the Pump Refill Procedure, and the updates to the card include:
- A description of the card’s purpose regarding pocket fill
- A reminder to clinicians of the critical steps for ensuring the pump is correctly refilled
- Detail regarding proper alignment of the refill template
- Information for actions to take if a pocket fill is suspected
- Removal of the note related to glucose testing
Medtronic has updated product manuals and is in the process of deploying the updated labelling. Current labelling for product manuals can be found at www.medtronic.com/manuals.
For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus, mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period of reduced concentration of drug will occur following the priming bolus.
Action
Through the 'Hazard Alert' letter, Medtronic is advising clinicians regarding ongoing patient management recommendations. Medtronic recommends following published guidance for managing all patients with intrathecal therapy, in addition to the following:
- Continue use of the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision.
- Monitor all patients following start or restart of intrathecal therapy. The post-procedure monitoring period will depend upon specific drug, dose administered and patient co-morbidities.
For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
The synchromed ii pump software update will automatically correct the following two issues:1) erroneous replace by date: the updated software corrects the issue previously communicated in medtronic’s march 2012 (tga ref: rc-2012-rn-00260-3) i.E., in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement.2) premature reservoir alarm: the updated software corrects the potential for premature low and empty reservoir alarms. these premature alarms are due to an incorrect calculation within the 8840 programmer software. the majority of these alarms occur within the clinic immediately following an interrogation.
Action
1) Medtronic does not recommend prophylactic explant of devices because these issues are addressed automatically and non-invasively with the software card update. Until the software application card is updated in the programmer:
- Clinicians may continue to use the present software card.
- Continue the normal follow up schedule, and monitor the estimated number of months until Elective Replacement Indicator (ERI).
- Follow labelled recommendations for pump replacement within 90 days of ERI declaration.
2) In the case of a low or empty reservoir alarm:
- Review the calculated residual volume displayed on the 8840 programmer to assess if the alarm is premature.
- After the software update, any previous version of the model 8870 software application card should no longer be used and can be returned to Medtronic.
For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-II-140204.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Medtronic has detected an upward shift in reports of over-infusion, defined as an infusion rate exceeding the programmed rate by more than 14.5% as described in the labelling. when over-infusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn is less than the volume expected. the device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm. over-infusion can result in a life-threatening overdose and/or drug withdrawal resulting from premature emptying of the pump. the onset of over-infusion has occurred as early as five months after implant and throughout the service life of the pump. reports indicate that once a pump has started to over-infuse, infusion rates can continue to increase, in some cases abruptly. the device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm.
Action
Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. Through the Hazard alert letter, Medtronic is recommending physicians on the appropriate management of patients implanted with the affected SynchroMed II pumps. Medtronic continues to investigate this issue and will be providing updates as more information becomes available. For further information, please refer to http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-140328.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Medtronic australasia pty limited is initiating a voluntary recall for a specific lot of our model 8551 refill kits. medtronic have identified that some refill kits in the affected lot may contain an extension tubing set that is occluded. healthcare professionals may be unable to aspirate or fill the synchromed pumps using one of these affected refill kits.
Action
Medtronic is requesting their customers to identify and segregate devices from the affected lot. Return of stock will be organised by Medtronic Customer Service.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
This communication is an update to medtronic’s march 2014 notification regarding the potential for synchromed ii pump over-infusion. “over-infusion” is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. pump reservoir contents that are less than expected may indicate that the pump has over-infused. over-infusion may or may not be associated with clinically relevant symptoms. when the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms. patients may experience under-dose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an over-infusing pump. the low reservoir alarm of an over-infusing pump will not sound if the pump reservoir is prematurely depleted. the low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume remaining in the reservoir.
Action
Medtronic is communicating the appropriate patient management recommendations and guidelines to the clinicians managing the patients implanted with the affected devices. For more details, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump . This action has been closed-out on 26/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
This action is a follow up to the july 2013 communication regarding the synchromed ii priming bolus function and to inform that medtronic is updating the model 8870 software application card as well as the synchromed infusion system labelling to address the issue. the software update will change the value displayed on the 8840 programmer for the synchromed ii pump tubing volume from 0.199 ml to 0.140 ml. over delivery of drug during priming bolus has the potential to lead to overdose symptoms in some patients. this software change mitigates the potential for unintended over-delivery of drug while still ensuring prompt therapy initiation. the synchromed ii infusion system manuals were updated for the priming bolus function, and new guidelines for priming have been implemented.
Action
Doctors are advised to continue to use the current software card and its displayed tubing volume until the Medtronic Representative has exchanged the current card with the new software card (new version is BBU01). New guidelines in labelling regarding priming bolus are identified in the customer letter and the attachment provided with the letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Medtronic is updating information communicated in july 2011 (rc-2011-rn-00769-3) regarding the failure rate for reduced battery performance in medtronic model 8637 synchromed ii pumps manufactured up to june 2011. updated failure rate information due to this issue:- pumps manufactured mar 2005 through dec 2010: 0.13% cumulative probability for pump failure at 72 months after implant. this rate remains within the failure rate upper bound of 0.2% reported in 2011.- pumps manufactured from jan 2011 through jun 2011: 3.17% cumulative probability for pump failure at 72 months after implant. this failure rate exceeds the upper bound estimate of 0.2% reported in 2011. a patient with a pump exhibiting reduced battery performance may experience return of underlying symptoms and/or withdrawal symptoms. patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not promptly and effectively treated.
Action
Medtronic is reinforcing the advice provided in 2011. Medtronic does not recommend prophylactic replacement of SynchroMed II pumps with the prior battery design (manufactured before July 2011) because of the estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery. If Low Battery Reset (critical alarm) or premature Elective Replacement Indicator (non-critical alarm) or End of Service (critical alarm) occurs, replacement surgery should be scheduled as soon as possible. Further ongoing patient management recommendations are detailed in the hazard alert communication provided to physicians. For further information, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump-0 .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Extra notes in the data
Reason
Medtronic is recalling the prior configuration of synchromed ii implantable drug infusion pumps, as a new configuration is available with an enhanced motor design. this recall action only relates to unimplanted devices.Medtronic has received regulatory approval for a design change to the synchromed ii implantable drug infusion pump. this design change of the motor decreases the potential for intermittent or permanent motor stall which can cause loss of therapy. all synchromed ii pumps are now being manufactured and distributed with this change.
Action
Medtronic will liaise with hospitals to review their inventory to locate affected pumps. Medtronic will arrange return and replacement of affected pumps.