BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVI SYSTEM

    MDR report key: 22919077 · Received August 28, 2025

    Report

    Report Number
    3012239564-2025-00014
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 27, 2025
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    UDI-DI
    07290017912226
    PMA / PMN Number
    K240037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DISCUSSION WITH THE BWM TEAM AND THE COMMUNICATION WITH THE PATIENT IN HER FOLLOW-UP MEETING., THE PATIENT HAD BEEN USING THE TREATMENT FROM THE US TRIAL, AND THE LAST TREATMENT PER THE REMOTE MONITORING LOG WAS (B)(6) 2025. IN THE MEETING ON (B)(6) THE PATIENT DID NOT WANT TO EXPLANT THE DEVICE AFTER DETERMINATION THAT THE IMPLANT IS NOT RESPONDING.

    Description of Event or Problem · 0

    THE PATIENT REPORTS THAT SHE HAS NOT BEEN ABLE TO INITIATE TREATMENTS FOR THE LAST COUPLE OF DAYS. SHE CHARGES HER ECU, SHE GETS RAPID BEEPING, BUT WHEN SHE PRESSES THE POWER BUTTON THERE IS NO RESPONSE, THERE IS NEVER A SWITCH TO THE GREEN LIGHT. PS DID A HARD RESET WITH THE PATIENT, THEN WHEN THE PATIENT ATTEMPTED TO START A TREATMENT SHE REPORTED HEARING CLICKING NOISES FROM THE WEARABLE, THEN A RED LIGHT, THEN THE DEVICE SHUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074404 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 71 YR Female Other