BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11703824 · Received April 21, 2021

    Report

    Report Number
    3010676138-2021-00076
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 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

    MRI WAS SCANNING SPINE WHEN SENSATION OCCURRED. MRI SCANNED THE 8TH AND 9TH THORACIC VERTEBRAE, WHICH IS WHERE BOTH STIMULATORS ARE IMPLANTED. 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, AND/OR MAGNETIC FIELD INTERACTING WITH OTHER NON-STIMWAVE IMPLANTS. STIMWAVE HAS CONFIRMED COMPLIANCE OF MRI FACILITY WITH THE IFU. X-RAYS WERE NOT AVAILABLE. THE CAUSE OF THE SHOCK/JOLT DURING MRI HAS IS UNKNOWN/NO PROBLEM FOUND. THE INVESTIGATION IS INCONCLUSIVE (NO FAULT FOUND), AS THERE IS NOT ADEQUATE INFORMATION AVAILABLE TO DETERMINE CAUSE.

    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
    596128 FREEDOM NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-RCV-A0, FR8A-SPR-B0 SWO181211, SWO190222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other