The U.S. Food and Drug Administration (FDA) and medical device manufacturer St. Jude Medical of St. Paul, MN are warning healthcare providers and patients about potential life-threatening problems with batteries in the company’s implantable defibrillators.
According to a medical advisory issued this week by the FDA, the integrated batteries in the defibrillators may lose power much more quickly than the normal three-month lead time indicated by the device’s elective replacement indicator (ERI). The problem is reportedly linked to deposits of lithium that form within the battery, creating abnormal electrical conditions that result in rapid battery failure. In some cases, batteries have reportedly lost power within 24 hours of the patient first receiving an ERI alert.
The FDA estimates that nearly 350,000 of the affected defibrillators are implanted in patients worldwide. The Wall Street Journal reports that two patients died when battery power in their implanted defibrillators was insufficient to power the devices, preventing them from providing the required shock therapy.