BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM PERIPHERAL NERVE STIMULATOR

    MDR report key: 19893196 · Received August 2, 2024

    Report

    Report Number
    3010676138-2024-00147
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 2, 2024
    Manufacturer
    CURONIX LLC
    Product Code
    GZF
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 STIMULATOR AFTER THE EXPIRATION DATE, NOT PREPPING THE SKIN WITH AN ANTISEPTIC SOLUTION, MULTIPLE TUNNELING ATTEMPTS, USING INAPPROPRIATE TOOLS, AND NOT PRESCRIBING ANTIBIOTICS PRE-OPERATIVELY HAVE BEEN RULED OUT AS POTENTIAL CAUSES. ADDITIONALLY, THE PATIENT TOUCHING OR PICKING THE WOUND HAS BEEN RULED OUT. HOWEVER, THE PATIENT HAS VASCULAR ISSUES AND THE INCISION SITE WAS NOT IRRIGATED WITH AN ANTIBIOTIC SOLUTION BEFORE CLOSURE. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO TWO IDENTIFIED ROOT CAUSES: PATIENT IS A POOR CANDIDATE DUE TO HEALTH, WEIGHT, AGE, OR MENTAL CAPACITY AS THE PATIENT HAS VASCULAR ISSUES (USER ERROR- CLINICIAN). SURGICAL ISSUE AS THE INCISION SITE WAS NOT IRRIGATED WITH AN ANTIBIOTIC SOLUTION BEFORE CLOSURE (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.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR RECEIVER SITE IS NOT HEALING AND THEIR ANCHOR SUTURES ARE VISIBLE. ANTIBIOTICS WERE PRESCRIBED AND THE PATIENT WAS REFERRED TO WOUND CARE. THE PATIENT IS CURRENTLY SEEING WOUND CARE AND THE WOUND HAS NOT YET HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741281 FREEDOM PERIPHERAL NERVE STIMULATOR PERIPHERAL NERVE STIMULATOR GZF CURONIX LLC STQ4-RCV-A0 SWO23107

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention