Starting June 22, 2022, Medtronic began alerting physicians that its Cobalt™ and Crome™ ICDs and CRT-Ds have the potential for reduced shock energy during therapy, which may affect the devices’ success in terminating irregular heart rhythms. We are instructing 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. There have been no reports of permanent patient harm or deaths due to this issue. Medtronic is aware of 27 devices out of ~80,000 distributed worldwide (as of June 3, 2022) that have experienced this reduced-energy shock.

Medtronic, in conjunction with its Independent Physician Quality Panel, is providing physicians comprehensive patient management guidance and does not recommend prophylactic device replacement.

Medtronic has developed a software update that will help mitigate this issue for patients implanted with these devices, and has submitted this update for regulatory approval. We anticipate that the update will be approved in the next one to two quarters.

CONTACTS:
Tracy McNulty, CRM
Kathleen Janasz, CRM