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.
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