Freedom Peripheral Nerve Stimulator

Description of Event or Problem

The patient reported "something" was sticking out of their leg, bruising, as well as the incision not fully closing. The patient was seen on (b)(6) 2026 and it was noted a suture had eroded on both sides of the incision site. However, there were no signs of infection. Additionally, X-Rays were performed which confirmed device migration of the right neurostimulator. The protruding sutures were clipped and a follow-up was scheduled for additional monitoring. Additional information was provided. The bruising had resolved and an explant procedure was performed on (b)(6) 2026. No further issues have been reported.

Additional Manufacturer Narrative

The Surgical Issue Questionnaire was reviewed for potential causes of the reported issue. Based on this review, implanting the device off-label, not performing an X-Ray immediately after the implant procedure to confirm device placement, and implanting the device after the expiration date have been ruled out. Additionally, severe force applied to the implant and the patient picking or touching the wound have been ruled out. Other potential causes of the reported issue include: not irrigating the incision site with an antibiotic solution before closure, not prepping the skin with an antiseptic solution, multiple tunneling attempts, using incorrect tools, improper surgical technique, and the patient having contraindicating conditions. A Curonix Representative conducted a review of sterilization and packaging records for the respective product lot; Curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.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 Surgical Issues. Surgical Issue rates remain acceptably low; thus, a CAPA is not required at this time. Surgical Issue rates will continue to be tracked and trended.