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

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.

• Contact your physician if you feel a vibratory alert. St. Jude Medical ICD and CRT-D devices are designed to deliver a vibratory alert to you when the battery is nearing its end of life. Immediately contact your physician if you feel the device’s vibratory battery alert. Devices affected by this advisory may reach end of battery life anywhere from within one day to several weeks after the vibratory alert has been delivered. If the device does deliver a vibratory alert due to low battery, it will need to be replaced.

• Register for home monitoring. St. Jude Medical devices are capable of home monitoring (Merlin@Home), which can alert your physician to a notification that the battery is approaching end of life. If you do not already use home monitoring for your device, and especially if you have difficulty recognizing your device’s end of battery alerts, you and your physician should consider whether home monitoring is appropriate for you.

• Seek immediate medical attention if you have symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath. These may be signs of a depleted battery.

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