STORY FROM: Drugs & Medical Devices
Batteries in Certain St. Jude Implantable Cardiac Defibrillators May Fail, FDA Warns
October 11, 2016
WASHINGTON, D.C. — The Food and Drug Administration has issued an alert warning doctors and patients that the batteries in certain St. Jude Medical cardiac defibrillators “ay fail earlier than expected,” shortening the normal three-month lead-time for device replacement.
In an Oct. 11 Safety Communication, the agency adds that some of the batteries in St. Jude’s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) have died within 24 hours of the patients receiving Elective Replacement Indicator alerts. St. Jude has initiated a recall and correction of the affected devices, according to the communication.
ICDs and CRT-Ds are both ...