Medtronic SynchroMed II implantable infusion pump

Hazard alert – risk of sudden loss of therapy due to reduced battery performance

11 May 2017

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a new hazard alert for model 8637 SynchroMed II implantable infusion pumps manufactured before the end of June 2011. The new hazard alert reinforces previously communicated patient management recommendation regarding the potential for sudden loss of therapy due to reduced battery performance, for which Medtronic Australasia had originally written to health professionals about in July 2011.

image showing implanted infusion pump

Medtronic SynchroMed II implantable infusion pumps are programmable medical devices that deliver small amounts of medicine directly into the spinal fluid for the treatment of chronic pain or muscle spasticity.

Please note, this hazard alert does not affect Medtronic SynchroMed II implantable infusion pumps currently being marketed or implanted, or to any previously implanted devices manufactured after June 2011. In June 2011, Medtronic Australasia began distributing infusion pumps with a new battery design that resolved this issue.

Information for consumers

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

If you or someone you provide care for has a Medtronic SynchroMed II implantable infusion pump, be alert for pump alarms. If you experience any change in symptoms or a return of underlying symptoms, such as chronic pain or muscle spasticity, and/or withdrawal symptoms, advise your managing health professional immediately.

If you are unsure if you have an affected device or if you have any questions or concerns regarding this issue, contact your managing health professional.

Information for health professionals

Medtronic Australasia has written to surgeons and neurologists who have implanted affected Medtronic SynchroMed II implantable infusion pumps or are managing patients who have these devices, providing further information regarding the above issue and up-to-date patient management recommendations.

Patients receiving intrathecal baclofen therapy are at risk of baclofen withdrawal syndrome, which can lead to a life-threatening condition if not promptly and effectively treated. As previously advised in July 2011, there has been one patient death attributed to this issue, which was determined to be caused by baclofen withdrawal syndrome. However, there have been no further reports of deaths directly attributed to this issue.

For further information about potential severity of withdrawal relating to other medicines used with this device, refer to the Product Information for that drug

For further information about the current patient management recommendations, or if you have any questions or concerns about this issue, contact Medtronic Australasia on 1800 652 972.

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.