In June 2022, Medtronic began alerting physicians to the potential for reduced shock energy during therapy in its Cobalt™ and Crome™ portfolio of ICDs and CRT-Ds, along with comprehensive patient management recommendations. At the same time, Medtronic asked hospitals to quarantine and return a subset of non-implanted Cobalt and Crome devices for inspection.
The FDA recently designated this voluntary action by Medtronic as a Class I recall. There have been no reports of permanent patient harm or deaths due to this issue.
Medtronic has received FDA approval and CE Mark for a software update to help mitigate this issue. The company began deploying the update into already-implanted Cobalt XT, Cobalt, and Crome devices via in-clinic device checks in mid-August 2022. Newly manufactured devices will have the update pre-installed starting this month.
In the original communication, Medtronic instructed physicians to set these devices at maximum energy output (40 joules); by programming to maximum output, the impact on the devices’ effectiveness is minimal (e.g., 99% efficacy to 98% efficacy) if the issue occurs.
What patients need to know
- Medtronic has regulatory approval for the software update that will help mitigate the issue, ensuring optimal device performance during high-voltage therapy delivery. That update will be applied via an in-clinic device check.
- Until patients’ next clinic visit, their devices will continue to provide pacing support, detect abnormal heart rhythms, record their heart information, and continue to send information to their clinic so the clinic staff can monitor patients’ hearts remotely. If patients hear a beeping tone coming from their device (the beeping tone will last for up to 30 seconds and will repeat every 4 hours), they should call their cardiologist’s office as soon as possible.
- If patients use a home bedside monitor that allows their physician’s office to remotely check the operation of their defibrillator, they should ensure that their home monitor remains plugged in at all times. If they use a cell phone (or other smart device such as a tablet) for remote monitoring, ensure the MyCareLink Heart app is open and active in the background on the smart device at all times.
Medtronic Patient Services is available to answer additional questions at (800) 551-5544 (Monday through Friday from 7 a.m. to 6 p.m. Central Time), or via email at pshelp [at] medtronic.com.
SOURCE: Medtronic