Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps
Recall for product correction and hazard alerts - three issues
18 July 2013
Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has initiated a recall for product correction for its Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps. Additionally, Medtronic Australasia is issuing two hazard alerts regarding two other issues that may affect Medtronic SynchroMed II and SynchroMed EL implanted infusion pumps.
Medtronic SynchroMed II and SynchroMed EL infusion pumps are implantable, programmable medical devices that deliver small amounts of medicine directly into the spinal fluid for the treatment of chronic pain or muscle spasticity.
The following three recall actions have been undertaken:
- Recall for product correction - pump refill procedure
- Hazard alert - internal feedthrough short circuit
- Hazard alert - priming bolus.
Please note that Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps are not being recalled from the market.
Medtronic Australasia has updated the clinician refill reference card for Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps in relation to pocket fills - the inadvertent injection of all or some of the medicine into the implanted pump pocket, instead of the pump itself. The reference card has been updated to align with the product labelling for newly manufactured devices.
- 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
- details regarding proper alignment of the refill template
- information for actions to take if a pocket fill is suspected
- removal of a note related to glucose testing.
Feedthroughs are components within Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps that provide an electrically-insulated path for current to flow from the electronic circuitry to the device's motor.
It has been identified that an electrical short circuit can potentially occur in a feedthrough. If this occurs, it may present as a motor stall or low battery reset/alarm.
A feedthrough short circuit may result in a loss or reduction in therapy, which can lead to the return of underlying symptoms and/or withdrawal symptoms.
It has been identified that there is the potential for unintended delivery of medicine during the priming bolus function when therapy is commenced with the Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps. This can lead to an overdose or underdose and related adverse events.
Medtronic Australasia has written to clinicians and surgeons who have implanted Medtronic SynchroMed II and SynchroMed EL infusion pumps, providing further information regarding the above issues and advice on how to treat affected patients.
If you have a Medtronic SynchroMed II or SynchroMed EL infusion pump implanted and have any questions or concerns regarding this device, please contact your surgeon or the hospital where the surgery was undertaken.
Patients who have had a Medtronic SynchroMed II and SynchroMed EL infusion pump implanted, and who have any questions or concerns about the above issue, should be referred to their surgeon or the hospital where the surgery was undertaken.
Medtronic Australasia has written to clinicians and surgeons who have implanted Medtronic SynchroMed II and SynchroMed EL infusion pumps, providing further information regarding the above issues and advice on how to treat affected patients. The recall for product correction letter and the two hazard alert letters regarding the above issues are provided below.
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- Medtronic - Pump refill procedure recall for product correction letter (pdf,528kb)
- Medtronic - Internal feedthrough short circuit hazard alert letter (pdf,260kb)
- Medtronic - Priming bolus hazard alert letter (pdf,260kb)
Please note that prophylactic replacement of this device is not recommended at this time. If a fault is identified, replacement surgery and/or alternative medical management could be considered, taking into account the individual patient's needs and circumstances.
If you have any questions or concerns regarding these issues, contact your local Medtronic Neuromodulation representative.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
Content last updated: Thursday, 18 July 2013
Web page last updated: Friday, 19 July 2013