BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22844212 · Received August 19, 2025

    Report

    Report Number
    3012239564-2025-00011
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    May 15, 2025
    Report Date
    August 18, 2025
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    UDI-DI
    07290017912226
    PMA / PMN Number
    K240037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REPORTED SHOCKING SENSATIONS DURING THE USE. CONCERN FOR A POTENTIAL NEUROLOGICAL ISSUE HAS LED TO A REFERRAL TO A NEUROLOGIST. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT SINCE ACTIVATION, THE PATIENT HAS HAD INCIDENTS OF "TREMORS" AND "SHOCKING" SEVERAL TIMES WHILE DOING TREATMENTS. THE FIRST TIME, THE PATIENT WENT TO THE ER, AND THE TREMORS WERE DOCUMENTED. A WEEK LATER, SHE EXPERIENCED BOTH TREMORS IN HER ARMS AND A SHOCKING NEAR THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436026 REVI SYSTEM IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD KA-9000-0001_US_CM 07290017912226

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other