Photo: Photo courtesy of Medtronic Medtronic’s operational headquarters in Fridley, Minnesota.
The U.S. Food and Drug Administration says the batteries in certain Medtronic pacemakers may drain more quickly than expected.
The FDA said Tuesday that it had notified and was working with Medtronic to monitor its affected implantable pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps).
According to the FDA, there have been three reports in which a 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. The FDA said 131,889 had been sold in the U.S. as of April 10.
The affected Medtronic 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
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The three reports affected devices implanted on average 7 months after being implanted, the FDA said. The devices are supposed to last between 7.5 and 15 years, or between 6 and 10 years before requiring battery replacement, depending on the device and the amount of pacing.
The FDA issued the following recommendations for patients and caregivers with potentially affected devices: Check that home monitoring transmissions are successful and occurring at the prescribed times so health care providers receive notifications of battery level drops to help inform care decisions.
Always keep the remote monitor plugged in.
The remote monitor must remain plugged in to ensure any wireless CareAlerts programmed by your health care provider and any automatically scheduled remote transmissions occur on time.
If you have an Astra device, do the manual transmission according to the schedule provided.
Monitor your MyCareLink Heart App on your smart phone to check for changes to your battery level.
Seek immediate medical care if you feel lightheaded, dizzy, chest pain, severe shortness of breath or if you are caring for someone who has lost consciousness. These may be signs your device’s battery has had a sudden drop or has drained.
Talk to your health care provider about whether your device is affected, how best to manage your medical condition and what actions to take with your device.
Contact Medtronic Technical Services Monday through Friday at 1-800-505-4636 if you have any questions.
You can find the FDA’s alert here .
Click here to view original web page at FDA: Certain Medtronic pacemakers may have battery-depletion issue