Freedom Peripheral Nerve Stimulator

Description of Event or Problem

During an implant procedure, the implanting clinician was unable to get consistent stim artifact and CMAP post suturing. As a result, the patient was under anesthesia for longer than 30 minutes. The neurostimulator was explanted and the implant procedure was aborted.

Additional Manufacturer Narrative

The Loss of Therapy/No Therapy Questionnaire was reviewed. Based on this review, not performing an X-Ray immediately after the implant procedure to confirm device placement, and no attempts to change the programs on the transmitter assembly have been ruled out. The neurostimulator associated with the complaint was returned for investigation. The investigation is currently in progress and has not yet been completed. The investigation will be updated when the investigation has been completed. The stimulator is used to treat pain. The cause of the reported issue is unknown. The investigation findings do not lead to a clear conclusion about the cause of the reported issue. Therefore, the conclusion has been selected as unable to determine the root cause.Rates reviewed at the most recent Complaint Trending meeting do not indicate a significant increase in Loss of Therapy/No Therapy. Loss of Therapy/No Therapy rates remain acceptably low; thus, a CAPA is not required at this time. Loss of Therapy/No Therapy rates will continue to be tracked and trended.