Defective batteries in some Medtronic SynchroMed II implantable infusion pumps, which the manufacturer has reportedly known about since 2009, have led the FDA to determine the pumps pose a serious risk of health problems or death for consumers, resulting in a Class 1 medical device recall.
Earlier this summer, Medtronic sent a letter to doctors warning that it had received at least reports of 55 battery problems with SynchroMed II infusion pumps, where the batteries became covered with a thin film that may cause the device to fail.
On Monday, the FDA announced that the battery failures and Medtronic’s warnings constitute a Class 1 recall, which is the most serious type of classification.
The Medtronic SynchroMed II Implantable Infusion Pump recall affects units with model numbers 8637-20 and 8637-40, which were distributed between May 2004 and July 8, 2011. Patients can visit a Medtronic device identification webpage and enter their device’s serial number to see if it is affected by the recall.
Despite being a recall, it is unlikely very many of the devices will be retrieved. More than 140,000 patients have already had the infusion pumps surgically implanted to release painkillers into the body.
The FDA and Medtronic recommend recipients of the defective infusion pumps make sure they carry their patient identification cards with them at all times and contact their doctor immediately if they hear the device begin to alarm or they begin to suffer a return of symptoms that the device is supposed to treat.
The sudden failure of the painkiller pumps may cause a patient to no longer receive medication, which can result in the return of pain symptoms and could also cause them to suffer drug withdrawal. In some cases, like with patients receiving intrathecal baclofen to treat multiple sclerosis, the withdrawal symptoms could be life-threatening. The pumps are designed to have an 84-month lifespan, but the premature failures have occurred as early as 48 months, the company has warned.
The company indicated in a press release issued in July that it has been aware of the problem since July 2009, when it sent a letter to physicians.
A new battery design has been put into place for future SynchroMed II pumps in Europe, Australia, New Zealand, Canada, Africa and India. Medtronic is still seeking approval for the design for pumps sold in the United States.