BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11562607 · Received March 24, 2021

    Report

    Report Number
    3010676138-2021-00052
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 22, 2021
    Report Date
    February 22, 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 PATIENT STATES HAVING BEEN IMPLANTED WITH AN SCS DEVICE, BUT SERIAL/LOT NUMBERS WERE NOT PROVIDED. THE CLINICAL REPRESENTATIVE WAS NOT PRESENT FOR THE IMPLANT PROCEDURE. BASED ON THIS INFORMATION, THE SHOCK/JOLT DURING MRI WAS UNABLE TO BE CONFIRMED/REPLICATED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED TO TREAT PAIN. SHOCK/JOLT DURING MRI CAN BE CAUSED BY MIGRATION, MAGNETIC FIELD CAUSING MECHANICAL MOVEMENT OF THE STIMULATOR WITHIN THE EPIDURAL SPACE, MAGNETIC FIELD INTERACTING WITH OTHER IMPLANTS, AND/OR THE MRI FACILITY NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). STIMWAVE HAS CONFIRMED PROPER MRI CONDITIONS. X-RAYS WERE NOT AVAILABLE, BUT WERE MENTIONED DURING INTERVIEW TO SHOW A REMAINING FRACTURED PIECE OF A PREVIOUSLY USED BOSTON SCIENTIFIC TENS UNIT THAT HAD BEEN EXPLANTED. IN THE IFU 05-20400 REV. 1, PREPARATION FOR AN MRI LINE 2 STATES: DO NOT CONDUCT AN MRI PROCEDURE IF THE PATIENT HAS ANY OTHER IMPLANT OR HEALTH CONDITION THAT PROHIBITS OR CONTRAINDICATES AN MRI EXAMINATION. IF THE PATIENT HAS ANOTHER IMPLANT, ESPECIALLY AN ELECTRONICALLY ACTIVATED OR "ACTIVE" DEVICE, THE SAFETY OF PERFORMING AN MRI WITH THE ADDITION OF FREEDOM-8A NEUROSTIMULATOR IS UNKNOWN. "IT IS UNKNOWN WHETHER FRACTURED PIECE OF BOSTON SCIENTIFIC TENS UNIT IS MRI COMPATIBLE; THIS COMPONENT MAY HAVE CONTRIBUTED TO THE ADVERSE MRI REACTION. THE CAUSE OF THE SHOCK/JOLT DURING MRI HAS NOT BEEN ATTRIBUTED TO THE IMPLANTED STIMWAVE DEVICE; THEREFORE, THE DHR WAS NOT REVIEWED. THE INVESTIGATION IS INCONCLUSIVE (NO FAULT FOUND), AS THERE IS NOT ADEQUATE INFORMATION AVAILABLE TO DETERMINE CAUSE. DESIGN FMEA 06-0537 AND HRA 06-0524 WERE REVIEWED TO CONFIRM INDUCED CURRENT FROM MRI AND OVERSTIMULATION DURING MRI ARE KNOWN ISSUES WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE. THUS, CAPA IS NOT REQUIRED. STIMWAVE'S GLOBAL MRI ADVERSE EVENT RATE IS (B)(4), AS OF (B)(4) 2020. THE FREQUENCY IS RARE AND SEVERITY IS CRITICAL.

    Description of Event or Problem · 1

    PATIENT REPORTS PAIN AND SHOCK/JOLT DURING MRI, AND THE MRI WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457557 FREEDOM NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other