Medtronic (NYSE:MDT) has issued an urgent field safety notice in Europe to warn of issues with its Percept PC implantable neurostimulator.
The notice’s purpose stands to inform customers of the potential failure with the Model B35200 Percept PC INS following a cardioversion procedure.
Fridley, Minnesota-based Medtronic determined that cardioversion may damage the electronics in the Percept PC INS device, making the INS unresponsive and non-functional, leaving the INS incapable of being turned back on, according to the notice. If therapy ceases, it will likely cause the return of disease symptoms.
In some cases, symptoms may return with a greater intensity than previously experienced by the user prior to implantation, which, in rare cases, can constitute a medical emergency.
Medtronic received four complaints on the issue from patients implanted with Percept PC between Jan. 14, 2020, and Oct. 4, 2021. All reported issues have resulted in or are planned for an explant procedure. A product event search from Jan. 1, 2018, to Sept. 9, 2021, did not detect any reports of the issue occurring with Model 37601 Activa PC, Model 37612 Activa RC or Models 37602 and 37603 Activa SC devices.
The company said it is working on updating the information in its manual to add warning language specific to cardioversion while also investigating additional mitigations and potential design changes to reduce the likelihood of cardioversion-related damage to the INS.