![]() Where possible, take advantage of the CareLink™ home monitoring system and the wireless low battery voltage CareAlert.Data suggests that battery failure is less common in patients who use the battery most, such as for frequent pacing support and higher voltage therapy.Continue normal follow-up per local clinical protocol.The letter gave the following information: Patient Management Guidance ![]() On February 3, 2021, Medtronic sent an Urgent Medical Device Correction letter to all affected health care professionals. Patients who require care using he affected Evera and Visia family ICDs, Viva, Claria, Amplia, and Compia Family CRT-Ds.Health care providers using the affected Evera and Visia family ICDs, Viva, Claria, Amplia, and Compia Family CRT-Ds.There are 264 Medical Device Reports, with 18 injuries including people experiencing bradycardia (slow heart rhythm) or heart failure symptoms. There have been 444 complaints regarding these devices. The likelihood that this issue will occur is constant after approximately three years after device use. If the user does not respond to the first warning, the device may stop functioning. Some devices may progress from “Recommended Replacement Time” to full battery depletion within as little as one day. ![]() The decrease in battery life is caused by a short circuit and will cause some devices to produce a “Recommended Replacement Time” (first warning that the battery is low) earlier than expected. Medtronic is recalling the specified ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. A person may need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure. ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called "leads" that go into the heart. Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
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