St. Jude Medical Warns of Rapid, Unexpected, and Potentially Lethal Battery Depletions With ICDs, CRT-Ds
St. Jude Medical is issuing a “recall and correction” and warning physicians and patients that the batteries in certain brands of the company’s implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices may fail much more rapidly than expected.
Rather than having the normal 3-month lead time to allow for device replacement, these devices are draining completely within 24 hours of the “vibratory alert” that warns that the battery is low.
At least two patients have died after devices failed to provide needed shock therapy due to premature battery depletion. In addition, almost 50 patients have reported fainting or dizziness from devices with batteries that had depleted prematurely, thereby preventing needed pacing therapy.
St. Jude issued the “important medical device advisory” early this morning. The US Food and Drug Administration (FDA) followed swiftly with a “safety communication” providing additional details. It is the FDA notice—not the St. Jude advisory—that uses the term “recall and correction.” Both the company and the FDA note that prophylactic device replacement is not recommended unless the treating physician deems it necessary, in which case St. Jude is providing a replacement device for free.
The company notes that the problem is rare—841 devices out of 398,740 devices sold worldwide have been returned for analysis. A total of 13 brands, manufactured before May 2015, are covered by today’s announcement. The rapid battery depletion appears to be caused by the formation of lithium clusters in the lithium-based batteries that power these devices, creating abnormal electrical connections that lead to rapid battery failure.
St. Jude is asking physicians to contact their patients to discuss the problem. Patients are being told to advise their physicians immediately when they feel the vibratory alert. They are also being urged to enroll in St. Jude’s remote monitoring service, where available—Merlin.net.
The company notes that its pacemakers are unaffected by the battery depletion problem.
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St. Jude Medical - Important Medical Device Advisory. http://media.sjm.com/newsroom/news-releases/news-releases-details/2016/St-Jude-Medical---Important-Medical-Device-Advisory/default.aspx. Published and accessed on: October 11, 2016.
Food and Drug Administration. Premature battery depletion of St. Jude Medical ICD and CRT-D devices: FDA safety communication.http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm524666.htm. Published and accessed on: October 11, 2016.