BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11819897 · Received May 13, 2021

    Report

    Report Number
    3010676138-2021-00090
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 13, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021, THE DEVICE WAS SUCCESSFULLY EXPLANTED. SURGICAL ISSUE QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, THE PATIENT INTERVENING WITH THE WOUND, PATIENT ENGAGING IN ANY PHYSICAL ACTIVITY, INCLUDING TWISTING, STRETCHING HAVE BEEN RULED OUT AS POTENTIAL CAUSES. HOWEVER, AN INCORRECT SURGICAL TECHNIQUE WAS USED.THE IMPLANTING CLINICIAN EXPLAINED TO THE CLINICAL REPRESENTATIVE THE EROSION HAPPENED BECAUSE OF AN IMPROPER POCKET TECHNIQUE: THE COIL WAS NOT PLACED DEEPLY ENOUGH OR FASTENED TO THE FASCIA. THE IMPLANTING CLINICIAN STATED AN INFECTION WAS NOT PRESENT. THE IMPLANTING CLINICIAN AND THE PATIENT AGREED TO PERFORM A REVISION AFTER THE PATIENT IS FULLY HEALED FROM THE EXPLANT. 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 CAUSE OF THE EROSION IS DUE TO INCORRECT SURGICAL TECHNIQUE DUE TO CLINICIAN USER ERROR.

    Description of Event or Problem · 1

    THE TAIL END OF THE LEAD ERODED OUT OF THE PATIENT'S SKIN AND NEEDED TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717361 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. SWO191218, SWO191005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention