The issue, which affects the Azure and Astra pacemakers and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers, occurs when a ceramic capacitor cracks internally due to thermal-mechanical stress during manufacturing, Medtronic said.
That can result in current drainage leading to depletion, although it is not a battery performance issue, the Fridley, Minn.-based company said. Some 266,700 of the devices have been distributed worldwide, 131,889 of those in the U.S., according to the company and the FDA.
The federal safety watchdog said Medtronic reported three adverse events in which a cracked capacitor led to battery depletion without warning with one year and, in one case, contributed to the death of a patient.
In another case the device was replaced after the patient experienced dizziness during follow-up and the healthcare provider was unable to communicate with the device. No harm occurred in the third case because the device was not implanted after a connection with the device failed.
“Based on the low predicted rate of failure and the recent implementation of process and component enhancements, Medtronic expects few, if any, additional events to occur. Medtronic, in consultation with our Independent Physician Quality Panel, does not recommend device replacement. Physicians should continue normal patient follow-up in accordance with standard practice, and where possible, continue to utilize the low battery voltage wireless CareAlert (shipped ON), together with remote monitoring via CareLink home monitor or the MyCareLink Heart mobile app,” the company said. “Per the instructions for use, at each follow-up, verify the status of the implanted system as well as the clinical effectiveness of the device. Pay attention to any unexpected changes in remaining longevity estimates or the inability to interrogate the device and/or transmit data.”
The FDA said it approved a new manufacturing step this year designed to improve the detection of capacitor failure, and for a different capacitor.
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