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April 27, 2022
2 Min Read
Image courtesy of Mark Hayes / Alamy Stock Photo
A rare communication problem between the Medtronic Percept PC implantable neurostimulator (INS) model B3200 and the clinician and/or patient programmer systems has prompted Medtronic to issue an urgent field safety notice in Europe.
The company said that in rare instances (0.044%) the neurostimulator is unable to communicate with the programmer systems. When this happens, the device will continue to provide therapy to the patient within programmed parameters, Medtronic said.
Medtronic said it has received six confirmed reports of the issue, including five in the United States and one in Switzerland, between the Percept PC launched in January 2020 and the end of February 2022. The company said two devices were removed from the patients as a result of not being able to connect with the INS. Medtronic said it can perform an INS diagnostic and communication reset should this issue occur and the company is investigating changes to prevent this problem from happening.
This device communication issue may present in the following way:
If the clinician programmer is not able to communicate with the INS, the clinician programmer will display “Searching for Device”.
If the patient programmer system was set up, it will continue to communicate with the INS and allows therapy adjustments and group changes to be made within the clinician set limits; however, the patient programmer system will not be able to turn therapy off.
o If the patient has previously been given the ability to turn their device off without requiring close communication, their ability to do so will be maintained.
o If the patient has a bipolar group set up previously, they will maintain the ability to put the device into MRI mode.
If there is no communication with the INS during the implant procedure, troubleshooting may delay the surgical procedure, and may require a replacement INS. There have been no reports of this occurring during implant.
If there is no communication with the INS post procedure, it might not be possible to adjust therapy and may cause the patient to experience inadequate therapy (i.e., return of underlying disease symptoms). If communication cannot be restored to the INS (refer to recommended mitigation below), an unanticipated surgical intervention may be needed to explant and replace the INS.
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