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Patient Deaths Prompt Recall of Heart Devices

Following the deaths of two patients, St. Jude Medical is recalling its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The batteries in both medical devices can fail prematurely and put patients’ lives at risk.

"There have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion," St. Jude's vice president of quality control, Jeff Fecho, said in a statement to physicians.

The implantable medical devices being recalled provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. Both the ICDs and CRT-Ds are designed to vibrate at regular intervals as the battery is nearing depletion. Once the device emits an elective replacement indicator (ERI) alert, patients should have 90 days to have a new device implanted.

In the defective St. Jude heart devices, full battery drainage can occur rapidly, within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the medical device will fail to deliver life-saving pacing or shocks, which could be fatal.

Given the risks posed by the faulty pacemakers, the U.S. Food and Drug Administration (FDA) has also issued a safety advisory alerting patients, patient-caregivers, and physicians to respond immediately to ERI alerts. According to the FDA, 841 of the 398,740 affected devices sold worldwide have been returned due to premature battery depletion. Several of those defective devices resulted in patient harm, more specifically:

  • Two deaths have been associated with devices that could not provide needed shock therapy due to premature battery depletion.
  • Ten patients have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.
  • Thirty-seven patients have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

The FDA advised patients to seek immediate medical attention as soon as they receive a low-battery alert. The agency also instructed hospitals to immediately remove any unused devices affected by the recall and contact the manufacturer to receive corrected devices.

If you or someone you care about has suffered serious harm due to a defective heart device or other medical product, you may be entitled to compensation. To discuss your legal rights, don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation.