Medtronic SynchroMed II implantable infusion pump system

Related information

Hazard alert - risk of incorrect pump replacement scheduling and premature reservoir alarms

4 February 2014

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a hazard alert regarding two potential issues involving its SynchroMed II implantable infusion pump system. Medtronic Australasia is undertaking a recall for product correction to address these problems.

Medtronic SynchroMed II 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.

SynchroMed infusion pump locationFront panel of the 8840 N'Vision clinician programmer

The following two issues have been identified:

  • Risk of incorrect pump replacement scheduling – when used with the SynchroMed II implantable infusion pump, the programmer device may display an incorrect 'Replace by' date (it may be displayed as a series of question marks or as a date greater than 90 days from the time for elective replacement), which could result in the pump reaching end of service before it is replaced. If this happens, the patient may experience a return of underlying symptoms and/or withdrawal symptoms.
  • Potential for premature reservoir alarm – the SynchroMed II implantable infusion pump may emit premature low and empty reservoir alarms. If this happens, therapy will not be affected, but patients may make earlier than necessary refill appointments. The majority of these alarms have occurred within the clinic immediately after the device has been checked with the programmer device and, when checked, the calculation for remaining volume of fluid in the reservoir has been correctly displayed on the programmer device.

Medtronic Australasia will address both of these issues by updating the software of the programmer device, which will correct the problems at the patient's next scheduled visit.

As of 23 January 2014, there have been no reports of deaths or life-threatening injuries associated with these issues worldwide.

Information for consumers

Medtronic Australasia has written to health professionals who have implanted Medtronic SynchroMed II infusion pumps or are managing patients who have these devices, providing further information regarding the above issues and advice on how to treat affected patients.

If you have a Medtronic SynchroMed II infusion pump implanted and experience any return of underlying symptoms, such as chronic pain or muscle spasticity, and/or withdrawal symptoms, advise your managing health professional.

Once the software of the programmer device is updated, these issues will be corrected at your next scheduled visit.

If you have any questions or concerns regarding these devices, please contact your managing health professional.

Information for all health professionals

If you are treating a patient who has had a Medtronic SynchroMed II infusion pump implanted, and they have any questions or concerns about the above issues, refer them to their managing surgeon or neurologist.

Reassure them that, once the programmer device software is updated, these issues will be corrected at their next scheduled visit with their managing surgeon or neurologist.

Advise them, if they experience any return of underlying symptoms, such as chronic pain or muscle spasticity, and/or withdrawal symptoms, to contact their managing surgeon or neurologist.

Information for surgeons and neurologists

Medtronic Australasia has written to surgeons and neurologists who have implanted Medtronic SynchroMed II infusion pumps or are managing patients who have these devices, providing further information regarding the above issues and advice on how to treat affected patients.

At their next scheduled visit, advise patients of this issue and to contact you if they experience any return of underlying symptoms and/or withdrawal symptoms.

Prophylactic removal of these devices is not recommended, as both issues will be addressed automatically and non-invasively with the update to the 8870 software application card (to version BBR01A) used by the 8840 N'Vision clinician programmer device.

Until the software application card is updated, you can continue to use the 8840 N'Vision clinician programmer device. If you receive an incorrect 'Replace by' date, continue the normal follow-up schedule and monitor the estimated number of months until the Elective Replacement Indicator (ERI). Follow labelled recommendations for pump replacement within 90 days of ERI declaration.

In the case of reservoir alarms, the calculation for remaining volume of fluid in the reservoir will be correctly displayed on the programmer device, so review that reading to assess if the alarm is premature.

After the 8870 software application card is updated, any previous version of the application card should no longer be used.

If you have any questions or concerns regarding these issues, contact your Medtronic Australasia field representative.

Reporting problems

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.