BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM PERIPHERAL NERVE STIMULATOR

    MDR report key: 23571057 · Received November 17, 2025

    Report

    Report Number
    3010676138-2025-00263
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 17, 2025
    Manufacturer
    CURONIX LLC
    Product Code
    GZF
    UDI-DI
    00850051034413
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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, AND USING INCORRECT TOOLS HAVE BEEN RULED OUT. HOWEVER, THE PATIENT WAS BOTHERING THE INCISION SITE BY APPLYING HYDROGEN PEROXIDE TO THE WOUND. ADDITIONALLY, THE PATIENT IS A HEAVY SMOKER WHICH MAY HAVE CONTRIBUTED TO THE IMPAIRED HEALING. 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 IMPAIRED HEALING IS DUE TO PATIENT NON-COMPLIANCE AS THE PATIENT WAS BOTHERING THE INCISION SITE BY APPLYING HYDROGEN PEROXIDE TO THE WOUND (USER ERROR-PATIENT). 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.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THE COIL INCISION AT THE COMMON PERONEAL NERVE WAS NOT HEALING. ANTIBIOTICS WERE PRESCRIBED, THE PATIENT WAS REFERRED TO WOUND CARE, AND THEY WERE ADVISED TO STOP SMOKING AND NOT APPLY HYDROGEN PEROXIDE TO THE WOUND. AS OF (B)(6) 2025, THE WOUND IS HEALING, THE PATIENT IS RECEIVING WOUND CARE, AND IT IS GOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273631 FREEDOM PERIPHERAL NERVE STIMULATOR PERIPHERAL NERVE STIMULATOR GZF CURONIX LLC STQ4-RCV-B0 SWO241115 00850051034413

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention