BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22835909 · Received August 18, 2025

    Report

    Report Number
    3012239564-2025-00010
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 19, 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

    DEVICE-STIMULATION RELATED EVENT - SOLVED BY CHANGING THE AVAILABLE TREATMENT OPTIONS ON THE ECU - REDUCTION OF TREATMENT STIMULATION LEVEL.

    Description of Event or Problem · 0

    PATIENT, (B)(6), CALLED TO REPORT NUMBNESS IN HER TOE ON HER LEFT FOOT DURING THE 2ND AND 3RD TREATMENT SESSIONS AND AFTER. SHE REPORTS FIRST FEELING NUMBNESS IN HER TOES DURING THE TREATMENT SESSION ON (B)(6). THE NUMBNESS DID NOT SUBSIDE UNTIL THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663597 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 63 YR Female Other