Freedom Peripheral Nerve Stimulator

Description of Event or Problem

The reported an infection in their left shoulder, that moved into their prosthetic shoulder joint. Antibiotics were prescribed and an explant procedure was performed on (b)(6)2026. As of (b)(6) 2026, the patient is recovering from the explant procedure. 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 after the expiration date, not prepping the surface of the skin with an antiseptic solution, not irrigating the incision site with an antibiotic solution before closure, improperly closing the surgical site, using incorrect tools, and not prescribing antibiotics pre-operatively have been ruled out. Additionally, the patient touching or picking at the wound, implanting the device off-label, and the patient having contraindicating conditions have been ruled out. However, multiple tunneling attempts were performed between the two incisions.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 infection is unknown. However, a Surgical Issue was identified as multiple tunneling attempts were performed between the two incisions (User Error- Clinician). 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.