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Home / Companies / News /  US FDA flags battery issues with Medtronic pacemakers

The US Food and Drug Administration (FDA) has raised an alarm about premature battery depletion in certain Medtronic pacemaker models, which could lead to devices losing power quickly and triggering a medical emergency.

The models affected by the battery issue include Azure, Astra, Percepta, Serena and Solara, according to the US regulator. The FDA, in its safety communication, alerted healthcare providers and patients about the batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps), which can drain faster than expected, without any warning.

CRT-Ps are battery-powered devices that provide pacing for slow heart rhythms and heart failure. Astra, Solara and Serena models are available in India.

If a capacitor–one of the electronic components of these devices–is cracked it may lose functionality and create an electric short, which can cause rapid battery depletion. “If the battery runs out, the device will be unable to deliver life-saving pacing, which could lead to serious injury or death," said the FDA late on Tuesday.

The move follows three events, wherein clinicians were unable to communicate with the device due to battery depletion, which resulted in loss of pacemaker function. “One of the cases resulted in the death of a pacemaker-dependent patient," the FDA added.

“While the number of adverse event reports associated with today’s safety communication is small and we expect very low rates of early battery depletion with this device, it’s important that patients and health care professionals ...pay close attention to devise performance given the pacemaker’s important, life-saving functions and discuss appropriate steps to reduce any potential safety risks to an individual patient," said William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality and chief medical officer in the FDA’s Center for Devices and Radiological Health, in a statement.

While the devices are designed to last between 7.5-10 years before their battery is required to be replaced, all three events occurred within a year of the device being implanted (average of 7 months).

Even as the FDA doesn’t recommend preventive removal and replacement of affected devices, it has cautioned the patients and professionals to carefully monitor battery status using home monitoring systems.

Medtronic said their devices continue to perform well within reliability projections.

“We expect few additional events to occur. 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 to continue with remote monitoring," Medtronic said.

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