St. Jude Defibrillators Receive FDA Warning

Following the deaths of two patients implanted with a St. Jude Medical defibrillator, the FDA has issued a warning concerning abnormal battery depletion in certain of the company’s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Affected devices include several models manufactured before May 2015 that may be prone to premature battery failure—some powering down less than 24 hours after the patient receives a low-battery alert—depriving patients of the 3-month replacement window the device allows under normal circumstances.

The cardiac devices are powered by lithium batteries. When build-up of the chemical element occurs inside the batteries, faulty electrical connections can cause rapid battery power drainage. Should the batteries die out, the defibrillator will not be able to maintain proper pacing for patients with heart arrhythmias. Therefore, the FDA advises patients and caregivers to immediately contact their physician if a vibratory battery alert is felt.

If you or a loved one received a St. Jude ICD or CRT-D defibrillator implant, please contact us.