FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries. The batteries may fail earlier than expected, and the 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.

Additional Resources:

St. Jude Medical – Premature Battery Depletion Information disclaimer icon