Medical Device Safety and Recalls: Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication

FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices.

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