BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 12037887 · Received June 21, 2021

    Report

    Report Number
    3010676138-2021-00131
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 22, 2021
    Report Date
    June 21, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL REPRESENTATIVE REPORTED THE PATIENT LOWERED THE HEAD, FELT SOMETHING STICKING OUT, AND ACCIDENTALLY PULLED THE LEADS OUT. THE OCCURRENCE TOOK PLACE FIVE DAYS INTO THE TRIAL. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH THE IMPLANTING CLINICIAN AND THE CLINICIAN DECIDED TO END THE TRIAL EARLY ON (B)(6) 2021. A STIMWAVE REPRESENTATIVE CONDUCTED A REVIEW OF STERILIZATION AND PACKAGING RECORDS FOR THE RESPECTIVE PRODUCT LOT; STIMWAVE 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 TRIAL LEADS COMING OUT FROM THE SKIN IS DUE TO PATIENT USER ERROR AND NON-COMPLIANCE.

    Description of Event or Problem · 1

    AN OCCIPITAL TRIAL PATIENT REPORTING LEADS COMING OUT FROM UNDER THE SKIN. THE IMPLANTING CLINICIAN REMOVED THE TRIAL LEADS ON (B)(6) 2021. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933920 FREEDOM NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-TRL-A0, FR8A-TRL-B0 SWO20112A, SWO210125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention