FDA Warns of Premature Battery Depletion With Certain Medtronic Pacemakers
So far, the batteries of three devices drained prematurely, leading to the death of one pacemaker-dependent patient.
The US Food and Drug Administration is issuing a safety communication informing patients and health professionals about the potential for premature battery depletion with Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-P).
To date, there have been three medical reports where the Medtronic pacemaker or CRT-P battery fully drained because of damage to the device’s capacitor. One patient died as a result of the damaged device and another patient experienced dizziness in follow-up that led to device replacement.
“If a capacitor in an implanted pacemaker or CRT-P is cracked, it can create an electric short, which can cause a battery to drain earlier than expected,” according to the FDA. “If the battery is completely drained, the device will no longer deliver pacing therapy. The patients who rely heavily on pacing or who are pacemaker dependent may be most at risk for having an adverse outcome.”
With all three medical device reports, the battery depletion occurred within 7 months of implantation. The pacemaker and CRT-P devices are powered by lithium-ion batteries, the key component of which is the capacitor that stores electrical energy. The pacemakers are designed to last anywhere between 6 and 15 years, depending on the device and type of pacing, before a battery replacement is required.
The Medtronic devices potentially affected with premature battery depletion include the Azure, Astra, Percepta, Serena, and Solara models. As of April 2019, more than 131,000 of the potentially affected pacemaker and CRT-P devices have been sold in the United States.
The FDA is not recommending prophylactic removal and replacement of the pacemakers, but they recognize that “some patients who depend on pacing for survival may determine, in consultation with you, that device replacement is appropriate for their needs.” For patients, the FDA is asking that they ensure home-monitoring transmissions are successful and occurring at the prescribed times so physicians can receive notifications if the battery levels decreases. Because of the low frequency of device failure, remotely monitoring battery status is appropriate given the greater risk of complications from removal, according to the agency.
At present, there is no way to identify or test when devices with the damaged capacitor and premature battery depletion are approaching the elective replacement indicator (ERI) alert notification, which warns that the battery is close to its end and needs to be replaced. There is also no way to accurately determine how much battery life remains once the ERI appears.
“Once ERI is reached, an affected device is unlikely to have the standard 3 months of battery life remaining,” states the FDA. “Treat pacemaker-dependent patients with a device that has reached ERI as a medical emergency.”
The FDA recently approved a new step in Medtronic’s manufacturing process to better detect capacitor failures in new devices and also approved use of a different capacitor to reduce the risk of premature battery depletion.
This is the latest battery issue to affect implantable heart-rhythm devices. In 2016, St. Jude Medical faced similar battery-related problems with some of their implantable cardioverter defibrillator and CRT-defibrillator devices. In an advisory letter, the company warned physicians that the batteries in certain devices may fail within 24 hours—instead of the usual 3 months—of the initial alert warning that the battery was low.
US Food and Drug Administration. FDA alerts providers and patients to check for premature battery depletion in certain Medtronic pacemakers: FDA safety communication. Published on: May 7, 2019. Accessed on: May 7, 2019.