Last Friday Medtronic, Inc. issued an urgent alert regarding potential battery problems with their SynchroMed® II Implantable Drug Infusion Pump.
In a small percentage of the pumps, a film can form within the pump battery that may impact performance. According to the company, this can lead to the sudden loss of drug therapy and the return of pain 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 treated quickly and effectively.
As of May 31, 2011, there have been 55 confirmed cases of this issue from approximately 139,653 SynchroMed II pump implants worldwide. One person has died from the resulting drug withdrawal.
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 pain, have withdrawal symptoms or hear a device alarm.
While the SynchroMed II pump was designed to last up to 84 months, 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. Returned product analysis of these pumps showed that the alarms were functioning as designed.
Medtronic is not recalling the product from the field or recommending surgical removal of the devices unless a patient’s pump demonstrates reduced battery performance.
The company is working to obtain U.S. approval for a battery design change intended to prevent the issue from occurring in future pumps. They first alerted physicians to this issue in July 2009 and a design change request was sent to the FDA in 2010. The change has already been made in many parts of the world, including Europe, Australia, New Zealand, Canada, Africa and India.
Patients with questions relating to this issue are encouraged to talk with their physicians or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT. Patient information can also be found on Medtronic’s website.
Note: This problem does not apply to Medtronic external insulin pumps for diabetes.
Medtronic Issues Communication about the Potential for Reduced Battery Performance in a Small Percentage of SynchroMed® II Implantable Drug Infusion Pumps. News Release. July 8, 2011.
Moore, Janet. Medtronic alerts doctors on pump problem. Star Tribune. July 11, 2011.