BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE

    MDR report key: 23159521 · Received September 26, 2025

    Report

    Report Number
    3012239564-2025-00016
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    PMA / PMN Number
    K240037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "PATIENT CALLED TO REPORT ISSUE WITH WEARABLE NOT CONNECTING WITH HER REVI IMPLANT", "BEHAVIOR INDICATIVE OF AN IMPLANT MALFUNCTION", PATIENT "IS STARTING TO SEE SYMPTOMS RETURN", AND COURSE OF ACTION IS "EX-PLANTATION OF THE IMPLANT AND RE-IMPLANTATION."

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT ISSUE WITH WEARABLE NOT CONNECTING WITH HER REVI IMPLANT SINCE (B)(6) 2025. SHE MADE AN APPOINTMENT WITH DR. (B)(6) TO HAVE THE ISSUE RESOLVED IN THE OFFICE, BUT HE REFERRED HER TO PATIENT SUPPORT FOR FURTHER HELP AND REPORTED TO BWM ON (B)(6) 2025. SHE HAS NOT HAD ANY TREATMENTS FOR A WEEK NOW AND IS STARTING TO SEE SYMPTOMS RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112151 IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD KA-9000-0001_US_CM

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other