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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.
Management of your implanted device and your medical condition must be individualized. You should consult with your health care provider to determine the best course of action.
Read the full FDA recommendations here: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm524666.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery