Battery problems with certain Medtronic pacemakers may cause the devices to suddenly fail, according to a warning issued by federal health officials, who indicate that at least one death has already been linked to the battery problems.
The FDA issued a safety communication on May 7, following three reports of problems where the lithium-ion battery in a pacemaker drained much quicker than expected. Of the three incidents, two involved patients reporting dizziness which ultimately lead to the discovery of the depleted batteries, requiring replacement. The third incident involved a patient death as a result of the Medtronic pacemaker battery failure.
Pacemakers are implantable devices positioned under the skin and are designed to assist the heart’s pumping action to treat fast, irregular, or slow heart rhythms, by applying small electric pulses to either one or both sides of the heart to keep the left and right chambers beating in proper sync. The devices are also used to treat patients susceptible to heart failure by improving the body’s ability to pump blood and distribute oxygen.
According to the warning, Medtronic discovered that certain resynchronization therapy pacemakers may be equipped with ceramic capacitors that are susceptible to cracking due to exposure to thermal-mechanical stress during the manufacturing process. The capacitor is a ceramic electrical component that stores the device’s power. The crack may cause an electrical short and deplete the battery in a matter of days.
The affected pacemakers are used in tandem with Medtronic’s MyCreLink monitor, which is designed to receive an Elective Replacement Indicator (ERI) CareAlert notification when the battery life of the devices drop below a certain level. However, Medtronic indicates this alerting feature may fail in the event the capacitor experiences a short, leaving patients and monitoring physicians without any alert or warning that the device will stop working in the near future.
The warning includes certain Medtronic Azure models W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01, Astra models X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01, Percepta models W1TR01, W1TR04, W4TR01, W4TR04, Serena models W1TR02, W1TR05, W4TR02, W4TR05, and Solara models W1TR03, W1TR06, W4TR03, W4TR06.
The warning impacts approximately 266,700 Medtronic pacemakers distributed worldwide, with 131,889 of those sold to healthcare facilities throughout the United States.
Medtronic announced they have a low prediction rate of additional failures and are advising healthcare physicians to continue normal follow-up with their patients to verify the status of the implanted system as well as the clinical effectiveness of the device. Patients with the implanted and affected devices are encourage to seek emergency medical treatment if they begin to experience lightheadedness, dizziness, chest pain, severe shortness of breath or if they lose consciousness.
At this time Medtronic is not recommending physicians replace the batteries of the affected pacemakers, stating patients may experience a higher risk of injury or death from infection during the replacement surgery when compared to the odds of the battery failing.
The FDA urges doctors and patients to report all adverse events linked to the use of these implants to the agency’s MedWatch adverse event reporting program.