FDA Warns Medtronic Pacemaker Patients About Potential Fast-draining Battery

Following a patient death, the U.S. Food and Drug Administration is warning users of certain Medtronic pacemakers about a rare battery problem that could cause the devices to quickly lose power and lead to a medical emergency for pacemaker-dependent patients.The FDA published an alert Tuesday that said Medtronic discovered a problem in which a crack can form in a ceramic electric component in some pacemakers and resynchronization pacemakers, leading to rapid battery depletion possibly without triggering the early replacement indicator.A pacemaker is an implantable device that can sense an abnormally slow heart beat and deliver mild electric current to one side of the heart to bring the rhythm back into healthy range. A resynchronization pacemaker, sometimes known as "CRT-P," is capable of pacing both sides to restore a well-organized heart beat in a patient who has heart failure.Tuesday's FDA alert applies to various models of Azure, Astra, Percepta, Serena and Solara pacemakers, which contain a capacitor that is vulnerable to cracking. As of last month, Medtronic had sold 131,889 of the devices in the U.S. The FDA has since approved Medtronic's request to use a different capacitor in the devices.Tuesday's alert is not classified as a recall, and the agency is not specifically recommending anyone have their pacemaker removed prophylactically.However, the alert said patients whose pacemakers need to work constantly to keep them conscious and alert -- known as "pacemaker-dependent" patients -- should carefully monitor their battery life through home-monitoring services.Although the devices may fail without tripping an early replacement indicator (ERI), the alert says pacemaker-dependent patients who do get an ERI warning should be treated as a medical emergency.The alert says one of the three reported device failures resulted in the death of a pacemaker-dependent patient. A second case resulted in a patient who felt dizzy, and had their device replaced when the physician realized the battery was depleted. The third case involved a device that was not implanted when the physician realized the battery problem."Based on the low predicted rate of failure, we expect few, if any, additional events to occur," a Medtronic spokeswoman said in an e-mail Tuesday. "In consultation with our Independent Physician Quality Panel, we do not recommend device replacement, and advise physicians to continue normal patient follow-up in accordance with standard practice and, where possible, to continue with remote monitoring."Joe Carlson, Minneapolis Star Tribune (TNS)  Continue reading...

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