The U.S. Food and Drug Administration (FDA) issued a safety alert in May regarding the batteries of implantable pacemakers and cardiac resynchronization therapy pacemakers (CRT-P) from the medical device company, Medtronic.
The FDA received three reports of patients’ pacemakers draining their charge well ahead of their designed battery life due to cracks in the capacitor that helps maintain the charge. One patient died as a result, and another required medical attention.
Pacemakers are devices implanted under the skin of the chest that uses wires to send an electric charge to the heart that corrects irregular heartbeats or heart failure. Pacemakers designed by Medtronic are meant to last between 7.5 and 15 years, or 6 and 10 years for CRT-Ps, before requiring a battery replacement.
The defective devices lost their charge about a year after implantation. If pacemakers lose their charge, they will stop delivering pacing therapy to the heart, which can lead to symptoms like shortness of breath, dizziness, chest pain and/or lightheadedness as the heart loses its stability. Without timely intervention, these heart complications can lead to death.
To date, Medtronic has sold approximately 132,000 of these devices. The models listed in the safety alert include:
- 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
- Solara models: W1TR03, W1TR06, W4TR03, W4TR06
FDA Recommendations
The FDA did not recommend removal and replacement of all affected devices. Instead, they suggested that patients with Medtronic devices consult their health care provider and determine the best course of action on a case-by-case basis.
Patients and providers should watch for decreases in battery level that are not in proportion to the expected battery life. If the device issues an Elective Replacement Interval (ERI) warning early, patients must immediately replace the device. Devices ordinarily issue ERIs with three months of battery life left, but with faulty devices, there is no guarantee that will be the case.
Patients should continue to use their remote monitors that allow providers to monitor the status of their pacemakers, and leave CareAlerts “ON." For all Azure, Percepta, Serena and Solara devices, patients should leave their monitors turned on to ensure that scheduled data transmissions are sent automatically.
For all Astra devices, which do not have wireless capabilities and automatic transmissions, patients should stick to a schedule to manually send in transmissions. Patients and caregivers with smartphones should also utilize the MyCareLink Heart App to monitor battery life.
If a patient feels any dizziness, chest pain, lightheadedness or severe shortness of breath, or if a patient loses consciousness, they should receive immediate medical attention.