May 7, 2019
“As part of our ongoing commitment to advance medical device safety, the FDA monitors for emerging safety concerns once a medical device is on the market and takes action when we become aware of issues that have the potential to put patients at risk. 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 who rely on these devices know to pay close attention to device 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. “To further reduce the risk of this issue, the FDA recently approved improvements to Medtronic’s manufacturing process and a new component for newly manufactured pacemakers. We’ll continue to work with Medtronic to monitor impacted devices for any related adverse events and will keep the public informed should new information become available.”
Today, the U.S. Food and Drug Administration issued a safety communication to inform patients and health care professionals about the potential for the batteries of certain Medtronic implantable pacemakers to drain more quickly than expected and without warning to patients. Implanted pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) are battery-powered devices that provide pacing for slow heart rhythms and heart failure. 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.
To date, the FDA is aware of three events related to this issue where clinicians were unable to communicate with the device due to battery depletion resulting in loss of pacemaker function. One of the events resulted in the death of a pacemaker-dependent patient. Another patient experienced dizziness during follow-up and the clinician was unable to communicate with the device, which resulted in device replacement. These events occurred within a year of the device being implanted (average of 7 months); the devices are designed to last between approximately 7.5 and 15 years or 6 and 10 years before requiring battery replacement, depending on the device and the amount of pacing. The third event was identified prior to implant and therefore the patient was not adversely affected. Approximately 132,000 devices have been sold in the U.S. to date.
At this time, preventative (prophylactic) removal and replacement of affected devices is not recommended. Rather, patients and professionals should carefully monitor battery status using home monitoring systems. Due to the low frequency of device failure, the FDA believes these are appropriate mitigations for most patients, as patients could be at greater risk of complications from the surgical procedure required to replace the device. The FDA recently approved a new step in Medtronic’s manufacturing process developed to better detect capacitor failures in newly manufactured devices. Additionally, the agency approved Medtronic’s use of a different capacitor in newly manufactured devices to reduce the risk of premature battery depletion.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.