Device maker, Medtronic Inc, just wrote to physicians about potential reduced battery problems with its <"http://www.yourlawyer.com/topics/overview/medtronic_infusion_pump_recall">SynchroMed II Implantable Drug Infusion Pumps. Reuters noted that, as of May 31, 55 confirmed cases of battery reduction problems were received globally. About 139,653 devices have been implanted around the world. The issue does not affect Medtronic’s external insulin pumps for diabetes, said the drug maker.
Medtronic first issued a warning in July 2009 for the devices which are meant to administer pain medication, said Reuters. That warning was classified by the U.S. Food and Drug Administration (FDA) as a Class II recall, not its most serious, but a significant warning in that the device could cause temporary health problems or a slight risk of a serious nature, explained Reuters. Medtronic and the FDA are collaborating, said a Medtronic spokeswoman, on a design change for the device.
Last year, the FDA announced it was looking into ways in which to avoid problems linked to infusion pumps, which are popular medical devices that deliver fluids including nutrients and drugs, into the body via what Reuters described as a â€œbuilt-in software interface.â€
When the first issue surfaced, the FDA said there were potential device design and engineering problems with the pump, which is not currently being recalled, said Reuters. Also, according to Medtronic, it is not recommending that the devices be removedâ€”a surgical procedureâ€”unless a pump experiences battery performance reduction.
Medtronic said its review found that the problem is linked to a film that forms within the pumpâ€™s battery, which can cause an acute therapy loss and return of pre-existing or withdrawal symptoms, reported Reuters. For instance, patients with severe spasticity who take baclofenâ€”a muscle relaxer and antispastic medicationâ€”within the spine through the pump could suffer baclofen withdrawal syndrome, which can become life-threatening if not treated, said Reuters.
Medtronic said patients should carry their patient ID cards at all times and to contact their doctors if a device alarm is heard or symptoms return, said Reuters, which noted that Medtronic is seeking U.S. approval for a battery design change for future pumps. The change is in effect in Europe, Australia, New Zealand, Canada, Africa, and India.
Meanwhile, we recently wrote that Medtronic issued a recallâ€”an FDA Class I, its most seriousâ€”for the SynchroMed II Programmable Pump, SynchroMed EL Infusion System, and Refill Kits. These defective medical devices have been linked to 8 deaths.
The SynchroMed II Programmable Pump and the SynchroMed EL Infusion System are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patientâ€™s body. The Medtronic refill kit is used in refilling Medtronic implantable infusion pumps, with the exception of Medtronic MiniMed Infusion Pumps.
The FDA previously warned Medtronic in 2009 for failing to correctly report and fix problems with its SynchroMed pumps. The company said at the time that there hadnâ€™t been any deaths tied to the devices.