Medtronic is recalling seven of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) due to the risk of a shortened battery life. The ICDs and CRT-Ds included in the recall are Evera, Viva, Brava, Claria, Amplia, Compia, and Visia.
According to an FDA recall notice, there is a risk that these devices may have an unexpected and rapid decrease in battery life caused by a short circuit and will cause some devices to produce a low battery warning — Recommended Replacement Time (RRT) — earlier than expected. Some devices may progress from that first warning to a full battery depletion within as little as one day. If the user does not respond to the RRT warning, the device may stop functioning. The likelihood that this issue will occur is constant after about three years after device use, according to the notice.
FDA said there have been 444 complaints regarding these devices. The agency also noted that 264 medical device reports have been filed, with 18 injuries including people experiencing bradycardia (slow heart rhythm) or heart failure symptoms. No deaths have been reported.
These Medtronic devices are designed to provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. 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. 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.
In February, Medtronic sent an urgent medical device correction letter to all affected healthcare professionals. The letter recommended continued normal follow-up per local clinical protocol for patient management. The letter also noted that 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. Healthcare professionals were also encouraged to take advantage of the Medtronic CareLink home monitoring system and the wireless low battery voltage CareAlert, and to remind patients to contact their clinic if they hear an audible alert, especially if they are opting to delay clinic visits due to COVID-19 guidance.
If an unexpected RRT is observed, prompt replacement of the device should occur with the underlying clinical situation of the patient:
- For non-pacing dependent patients or for primary prevention ICD patients, replacement within one week of an unexpected RRT notification is recommended.
- For pacing dependent patients, immediate replacement is recommended following an unexpected RRT notification. Note: For all patients, this issue can also manifest as an unexpected change in the remaining longevity estimate cannot be attributed to programming changes, or changes in use conditions.
The letter also stated:
- Medtronic medical staff in consultation with an independent physician quality panel recommends against replacing the device due to the low rate of occurrence and the low risk for permanent harm if immediate replacement occurs in response to an unexpected RRT.
- Patients and clinicians may determine if a specific device is affected by looking up the serial number on Medtronic’s Product Performance website
Medtronic also included a clinician confirmation certificate with the letter and encouraged clinicians to complete and return it via email.