Freedom Peripheral Nerve Stimulator

Description of Event or Problem

The patient reported increased pain in their lower leg and no longer receiving pain relief. On (b)(6) 2026, the Commercial Team Member met with the patient and re-educated them on where to place the Transmitter Assembly Antenna to receive adequate therapy. Additionally, the power index was decreased on the Transmitter Assembly. Therapy has been restored and the pain resolved. The patient will follow-up with the Commercial Team Member to see how therapy is going.

Additional Manufacturer Narrative

The Loss of Therapy/No Therapy Questionnaire was reviewed for potential causes of the reported issue. Based on this review, never achieving therapy, implanting the device off-label, not performing an X-Ray immediately after the procedure to confirm placement, inadequate fixation, and no attempts to change the programs on the Transmitter Assembly have been ruled out. Additionally, improper surgical technique has been ruled out. However, the Commercial Team Member met with the patient to re-educate them on where to place the Transmitter Assembly Antenna to receive adequate therapy. The stimulator is used to treat pain. The cause of reported issue is due to Transmitter Assembly Antenna Placement as therapy was restored after the patient was re-educated on proper use (User Error - Patient).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.