FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers
The U.S. Food and Drug Administration (FDA) has issued a safety communication to alert health care providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers to drain more quickly than expected without warning patients or health care providers.
The implanted pacemakers and CRT-Ps have electronics and are powered by lithium-ion batteries. One of the key electronic components is a capacitor, which stores electrical energy.
Patients can use remote monitoring systems, such as Medtronic’s MyCareLink Monitor, to help their health care providers monitor battery status and general functioning of their implanted pacemaker or CRT-P. Health care providers receive CareAlert notifications through manual transmissions from the patient or wirelessly connecting to the patient’s implanted pacemaker or CRT-P when the patient’s device has CareAlerts programmed “ON.” The patient and health care provider receive an Elective Replacement Indicator (ERI) CareAlert notification when the battery level drops below a certain limit.
- Affected Medtronic implantable pacemaker and CRT-P device models 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
The FDA is aware of three medical device reports in which a Medtronic implantable pacemaker or CRT-P battery had fully drained because of a crack in the device’s capacitor, without any warning to the patient or health care provider. As of April 10, 2019, 131,889 have been sold in the U.S.
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. 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.
In all three medical device reports the FDA received, Medtronic reported that health care providers were unable to communicate with the device due to battery depletion, resulting in loss of pacemaker function. Medtronic also reported these events occurred within one year after the patient was implanted with the pacemaker or CRT-P, on average within seven months of getting the device implanted. 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. One of the reported events resulted in the death of a pacemaker-dependent patient. In a second reported event, the patient experienced dizziness during follow-up and the health care provider was unable to communicate with the device, which resulted in the patient getting their device replaced. In the third reported event, there was no harm to the patient because the device was not implanted when the health care provider became aware that a connection with the device could not be established.
Recommendations for Health Care Providers:
- Prophylactic removal and replacement of affected devices is NOT recommended, but the FDA recognizes that some patients who depend on pacing for survival may determine, in consultation with you, that device replacement is appropriate for their needs. Consider whether elective device replacement is warranted for any of your pacemaker patients due to pacemaker dependent status or other high-risk features.
- Be aware of sudden battery level drops during follow up visits and remote transmissions. Watch for decreases in battery level out of proportion to the life of the device from the time of implant even if the level remains within the normal range.
- Advise your patients to continue to use their remote monitors.
- For Azure, Percepta, Serena, and Solara devices:
- These devices have wireless CareAlerts programmed by the health care provider. The monitor must remain powered on to ensure automatically scheduled transmissions are sent. CareAlerts should be programmed to “ON.”
- For Astra devices:
- These devices do not have wireless capability and require manual transmission by the patient. To ensure timely transmission of any CareAlerts done manually by the patient, the patient should have a transmission schedule and CareAlerts should be programmed “ON.”
- For Azure, Percepta, Serena, and Solara devices:
- Replace the pacemaker or CRT-P immediately at the time of an ERI alert. Currently, there is not a factor, method, or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears. Once ERI is reached, an affected device is unlikely to have the standard three months of battery life remaining.
- Treat pacemaker-dependent patients with a device that has reached ERI as a medical emergency.
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