Recalls and Alerts
Medical Device Safety Alert: Medtronic SynchroMed II and SynchroMed EL pumps
The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning SynchroMed II and SynchroMed EL pumps, manufactured by Medtronic. 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 lead to a loss of or reduction in therapy which may result in the 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. Surgical revision to replace or remove the pumps may be required for patients with pumps experiencing repeated motor stalls, Low Battery Resets (with or without Safe State), or a premature Elective Replacement Indicator.
All SynchroMed II and SynchroMed EL pumps can potentially be affected by this issue at any time throughout the life of the device, regardless of drugs used in the pump. The SynchroMed EL has been discontinued and based on Medtronic data, at least 90% of the remaining actively implanted SynchroMed EL pumps are near expected end of service.
Medtronic has assessed reports of internal feedthrough shorting in the SynchroMed II pump since its release in 2004. There have been 380 relevant product events from approximately 181,400 pump implants worldwide. Medtronic’s analysis of returned products and reports data shows the cumulative failure probability for internal feedthrough shorting to be approximately 0.28% at 48 months and 0.69% at 84 months post implant.
For SynchroMed II, this issue may be exhibited as one or more of the following:
For SynchroMed EL, this issue may be exhibited as one or both of the following:
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. 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. Furthermore, the manufacturer provided the following ongoing patient management recommendations:
For details, please refer to MHRA website
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 19 June 2013