The U.S. Food and Drug Administration (FDA) has placed its most serious Class I label on a St. Jude Medical recall affecting hundreds of thousands of pacemakers prone to premature battery depletion. The devices in question are implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), which provide pacing in patients with slow heart rhythms and pacing or shocks in patients with fast heart rhythms. The recall affects certain models of the Fortify, Unify and Assura ICDs and CRT-Ds manufactured between January 2010 and May 2015.
A Class I recall is the most serious FDA recall status. The Class I designation indicates that exposure to a recalled device presents a reasonable risk of serious injury or death.
A total of 349,852 affected devices were distributed worldwide, 251,346 in the United States. Of these, 841 were returned due to premature battery failure. When the battery fails, the device can no longer deliver shocks or pacing, which can lead to death in some patients. Early battery depletion was linked to two deaths. St. Jude Medical also received 10 reports of patients fainting and 37 reports of dizziness because the battery could not supply the appropriate therapy.
The battery defect stems from a buildup of lithium. These “lithium clusters” can cause a short circuit, rapidly depleting the battery. Due to the battery defect, the FDA is urging patients and healthcare providers to respond to the elective replacement indicator (ERI) as soon as possible. Normally, the battery will last another three months after the ERI initially goes off, but there have been reports where the battery depletes within 24 hours of the ERI.
The decision on whether or not to remove the pacemaker should be determined by the physician, based on each patient’s situation. The FDA says that for most patients, monitoring is the best way to address the battery defect because removing the device presents its own risks and complications.
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