Medtronic (NYSE:MDT) has issued an urgent field safety notice in Europe regarding its Percept PC implantable neurostimulator (INS).
The letter informs users that, in rare instances (0.044%), the Percept PC INS Model B35200 can’t communicate with the clinician programmer and/or the patient programmer system (HH90 Handset and TM91 Communicator).
According to the safety notice, in these instances, the INS will continue to provide therapy within programmed parameters. Although the occurrence is rare, Medtronic said it warned users to raise awareness and inform and serve its customers.
If a clinician programmer can’t communicate with the INS, the programmer will display “Searching for Device.” If the patient programmer has been set up, it will continue to communicate with the INS and allow therapy adjustments and group changes to be made within clinician-set limits, but the patient programmer will not be able to turn the therapy off.
Patients who have previously been given the ability to turn their device off without requiring close communication will maintain their ability to do so. If the patient has a bipolar group set up previously, they will maintain the ability to put the device into MRI mode.
Troubleshooting may delay the surgical procedure and require a replacement INS if there is no communication with the INS during the implant procedure, although the company has not received any reports of such an event occurring during implant. No communication with the INS post-procedure may mean it is not possible to adjust therapy, potentially causing the patient inadequate therapy.
From when Medtronic launched Percept PC in January 2020 through the end of February 2022, the company has received six confirmed reports of the issue. Five reports occurred in the U.S., and one event took place in Switzerland. Two devices were explanted as a result of the inability to connect with the INS.
The company can perform an INS diagnostic and communication reset should the issue occur. Medtronic said it is investigating changes to prevent the occurrence.
Medtronic previously warned on an issue with the same model of the Percept system, announcing in 2021 that cardioversion may damage the electronics in the Percept PC INS device, making the INS unresponsive and non-functional. The situation could leave the INS incapable of being turned back on.