Medtronic Addresses Pumps’ Battery Performance Issue

Medtronic Inc. is issuing an urgent medical device correction regarding the potential for reduced battery performance in a percentage of SynchroMed II implantable drug infusion pumps. The issue, which does not involve external insulin pumps for diabetes, first was reported in a letter to physicians in 2009.

Medtronic will not retrieve pumps from the field, and will not recommend surgical removal unless the device demonstrates reduced battery performance.

As of May 31, 2011, there have been 55 confirmed cases of this issue from approximately 139,653 SynchroMed II pump implants worldwide, according to Medtronic. The SynchroMed II pump was designed to last up to 84 months, but these events occurred between 45 and 78 months after implant. All but one of the cases occurred in pumps with batteries manufactured prior to March 17, 2005. Analyses of returned products showed that the alarms were functioning as designed.

Company research indicates that the issue is related to the formation of a film within the pump battery that may impact battery performance, and can lead to the sudden loss of therapy and the return of underlying symptoms 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 treated quickly and effectively. Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.

The Minneapolis, Minn.-based company is working to obtain U.S. approval for a battery design change intended to prevent the issue from occurring in future pumps, which already has been implemented in several regions, including Europe, Australia, New Zealand, Canada, Africa and India.

Malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 800-328-0810, Monday-Friday, 8 a.m. to 5 p.m. CDT, and the U.S. Food and Drug Administration’s MedWatch Program at http://www.fda.gov/MedWatch.