Benzinga | Oct 21, 2021 12:10PM EDT

Medtronic Warns On Percept PC Implantable Neurostimulators In Europe

* Medtronic Plc (NYSE:MDT) has issued an urgent field safety notice in Europe to warn of its Percept PC Implantable Neurostimulator (INS) issues.

* The notice's purpose is to inform customers of the potential failure with the Model B35200 Percept PC INS following a cardioversion procedure.

* According to the notice, 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.

* If therapy ceases, it will likely cause the return of disease symptoms.

* In some cases, symptoms may return with greater intensity than previously experienced by the user before implantation.

* Medtronic received four complaints from patients implanted with Percept PC between January 2020 and October 2021.

* All reported issues have resulted in or are planned for an explant procedure.

* The Company is working on adding the 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.

* Price Action: MDT shares are down 0.02% at $122.18 during the market session on the last check Wednesday.