The U.S. Food and Drug Administration (FDA) is warning of premature battery depletion with St. Jude Medical Implanted Defibrillators, specifically St. Jude Medical ICD and CRT-D models manufactured prior to May 2015. The agency is reviewing possible cybersecurity issues that affect the battery of the heart devices. Out of 398,740 that were sold worldwide, 841 were returned for analysis, according to an Oct. 11 safety communication.
The FDA urges patients, caregivers and healthcare professionals to replace the battery as soon as the Elective Replacement Indicator (ERI) alarm goes off. Under normal circumstances, the battery should work for another three months following the ERI. However, the FDA is aware of cases where the battery depleted within 24 hours of the ERI alert. If the battery fails, the heart devices can no longer deliver life-saving therapy such as shocks or pacing. This can result in patient death. Patients who rely on a pacemaker or who have a high likelihood of needing a shock have the greatest risk.
Premature battery depletion has been linked to 2 deaths, 10 cases of fainting and 37 reports of dizziness. Some patients were unable to notice the ERI alert because the battery died immediately after the ERI. Close monitoring is the most appropriate solution at this point, since removing the defibrillators carries its own serious risks. The ICD should not be removed unless it is strictly necessary, the FDA says. All affected patients should receive a consultation and care should be individualized to each patient’s situation.
The battery depletion is caused by a buildup of lithium in the battery, known as “lithium clusters”. When this occurs it can cause the battery to drain quickly.