BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11675826 · Received April 15, 2021

    Report

    Report Number
    3010676138-2021-00071
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 15, 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 AN UNKNOWN DATE, THE PATIENT FOLLOWED UP WITH THE IMPLANTING CLINICIAN HE IMPLANTING CLINICIAN EXPLAINED TO THE PATIENT THAT THE LOCATION WHERE THE STIMULATORS WERE IMPLANTED IS CLOSE TO THE NERVE, CAUSING THE SHOCKING SENSATION EXPERIENCED BY THE PATIENT WHEN THE STIMULATORS ARE OFF. THE IMPLANTING CLINICIAN NOTED THE PATIENT IS PETITE, AND THE LACK OF TISSUE AROUND THE ANKLE MAY HAVE CONTRIBUTED TO THE EVENT. THE IMPLANTING CLINICIAN ASKED THE CLINICAL REPRESENTATIVE TO REPROGRAM THE PATIENT TO A LOWER FREQUENCY. THE CLINICAL REPRESENTATIVE PROVIDED THE PATIENT WITH A NEW WAA DURING THIS VISIT. THE IMPLANTING CLINICIAN CONFIRMED THE STIMULATORS REMAIN AT THE SAME POSITION. THE PATIENT AND IMPLANTING CLINICIAN HAVE AGREED NOT TO PERFORM A REVISION/EXPLANT PROCEDURE AT THIS TIME. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED FOR THE TREATMENT OF PAIN. THE CAUSE OF THE "SHOCK" SENSATION IS DUE TO THE IMPLANT PLACEMENT TO NEAR TO THE NERVE IN A REGION WITH LIMITED TISSUE. DESIGN FMEA 06-0537 AND HRA 06-0524 WERE REVIEWED PAINFUL AND OVERSTIMULATION ARE KNOWN ISSUES WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE THEREFORE, NO CAPA IS REQUIRED. THE IMPACT IS IMPORTANT AND STIMWAVE'S GLOBAL DISCOMFORT RATE: 0.06%.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT REPORTED EXPERIENCING A SHOCKING SENSATION NEAR THE IMPLANT SITE IN THE ANKLE TO THE CLINICAL REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567018 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0, STQ4-SPR-B0 SWO200929, SWO201008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other