Device maker Medtronic, Inc. issued an urgent Medical Device Correction regarding models of implantable infusion pumps because low battery problems may cause the devices to fail. The two models are numbered 8637-20 and 8637-40 and were distributed between May 2004 and July 8, 2011. The pump is called Synchro®Med II implantable drug infusion pump.
The pumps are used to deliver the chronic infusion of drugs or fluids. The device is indicated for supplying to the patient morphine sulfate, ziconotide and baclofen to treat chronic pain, severe chronic pain, and severe spasticity, as well as floxuridine and methotrexate to treat primary or metastatic cancer.
According to the U.S. Food and Drug Administration (FDA), the battery problem has to do with the formation of a film within the pump battery. Sudden loss of drug therapy can lead to return of underlying symptoms and drug withdrawal symptoms.
In the case of baclofen for severe spasticity, the loss of drug treatment can lead to baclofen withdrawal syndrome, which if not treated properly and quickly, can be life threatening.
The battery problem does not affect external insulin pumps for diabetes.
The manufacturer is not recommending the devices be surgically removed unless a patient’s pump indicates the battery is low. The reasons given for not removing any pumps before the occurrence of problems, Medtronic said, is because the problem has a low occurrence rate, pump alarms can warn patients of any problems, and that risks are associated with implant replacement surgery.
Out of 139,653 Synchro®Med II infusion pumps implanted worldwide, 55 batteries had been affected as of May 31, 2011, according to a news release issued by Medtronic on July 8, 2011. Even though the pump was designed to work for up to 84 months, these failures occurred between 45 and 78 months after the batteries were implanted.
Medtronic said it is in the process of obtaining approval in the U.S. for a revision in the battery to prevent the failure in the future. Countries and regions where the design change has already been approved include Europe, Australia, New Zealand, Canada, Africa and India.
Patients are encouraged to carry their patient identification cards with them at all times.
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