BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22900883 · Received August 26, 2025

    Report

    Report Number
    3012239564-2025-00013
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 26, 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 HAD PAIN DOWN HER FOOT BELOW THE INCISION SITE, AND HER HEEL IS NUMB AND FOLLOWING TIMED OUT SESSIONS OF ECU, STOPPED THE TREATMENT. PATIENT IS EXPECTING TO GET THE IMPLANT REMOVED, BUT IT HASN'T BEEN SCHEDULED YET.

    Description of Event or Problem · 0

    PATIENT CAME INTO THE OFFICE FOR A 6-MONTH FOLLOW-UP VISIT. SHE SAID THAT SHE HAS BEEN EXPERIENCING PAIN DOWN HER FOOT BELOW THE INCISION SITE AND THAT HER HEEL IS NUMB. SHE WANTS THE IMPLANT REMOVED. SHE IS LOOKING TO SCHEDULE THE IMPLANT REMOVAL FOR THE MIDDLE OF AUGUST. SHE ALSO STATED THAT SHE HAD A LOT OF DIFFICULTY WITH THE WEARABLE AND THAT IT WOULD TAKE HER OVER AN HOUR TO COMPLETE A TREATMENT BECAUSE IT CONSISTENTLY TIMED OUT. SHE STOPPED USING IT ALTOGETHER OVER A MONTH AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250450 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 36 YR Female Other