- Medtronic Plc 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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