FDA Issues Safety Alert For ICD and CRT-D Devices Due to Battery Failure
The U.S. Food and Drug Administration (FDA) has issued a safety alert for St. Jude Medical implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured before May 2015 because of premature battery failure. Instead of batteries lasting about three months after an Elective Replacement Indicator alert goes off, St. Jude has reported that the batteries in the devices could be drained within a much shorter timeframe, ranging from one day to a few weeks. This rapid battery failure is associated with two known deaths, as well as reported fainting and dizziness from approximately 50 patients. Almost 350,000 devices remain implanted. St. Jude has initiated a recall of the faulty devices. Patients are advised to register for St. Jude home monitoring and to seek immediate medical attention if lightheadedness, dizziness, chest pain, shortness of breath or loss of consciousness are experienced, or if a vibratory alert is felt. The FDA will continue to monitor the affected devices for any adverse events related to the battery depletion and will keep the public informed throughout the process.
Read the FDA announcement here.
Keywords: Cardiac Resynchronization Therapy, Cardiac Resynchronization Therapy Devices, Chest Pain, Defibrillators, Implantable, Dizziness, United States Food and Drug Administration
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