BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11429567 · Received March 7, 2021

    Report

    Report Number
    3010676138-2021-00031
    Event Type
    Injury
    Date Received
    March 7, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 4, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    PMA / PMN Number
    K171366
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD REPORTED A SHOCKING FEELING DURING AN MRI LAST YEAR. THE PATIENT ADDED THAT THIS DISCOMFORT WAS NOT EXPERIENCED BEFORE MRI. THE PATIENT HAD A FOLLOWED-UP APPOINTMENT WITH THE IMPLANTING CLINICIAN AND THE CLINICAL REPRESENTATIVE. DURING THIS VISIT, X-RAYS WERE PERFORMED, AND THE IMPLANTING CLINICIAN CONFIRMED THAT MIGRATION HAD NOT OCCURRED. THE CLINICAL REPRESENTATIVE DECIDED TO REPROGRAM THE PROGRAM SETTINGS. THE OUTCOME OF THE REPROGRAMMING WAS TO LOWER THE SETTINGS TO AVOID THE PATIENT EXPERIENCING OVERSTIMULATION. THE CLINICAL REPRESENTATIVE BELIEVES THE PARAMETERS MIGHT HAVE BEEN SET TOO HIGH. BASED ON THIS INFORMATION, THE SHOCK/STABBING SENSATION WAS NOT CONFIRMED/REPLICATED. THE MILD STABBING SENSATION FELT BY THE PATIENT COULD BE ELECTRICAL SENSATION/PARAESTHESIA. BASED ON THE STIMULATOR INVESTIGATION, THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE STABBING SENSATION IS USER ERROR SINCE THE PARAMETERS SETTINGS MIGHT HAVE BEEN TOO HIGH, CAUSING OVERSTIMULATION. DESIGN FMEA 06-0537 AND HRA 06-0524 WAS REVIEWED AND PAINFUL/OVERSTIMULATION DUE ARE KNOWN ISSUES WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT CONTACTED THE CLINICAL REPRESENTATIVE TO REPORT "STABBING" PAIN IN THE RIGHT SIDE OF THE BACK CAUSED BY SPECIFIC MOVEMENTS; "SKIN IS NUMB" AND FEELS DIFFERENT FROM THE REST OF HIS SKIN IN THE RIGHT ABDOMEN AND SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325310 FREEDOM NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-RCV-A0, FR8A-SPR-B0 SWO191103, SWO191113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other