BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 25200928 · Received May 18, 2026

    Report

    Report Number
    3012239564-2026-00021
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    December 24, 2025
    Report Date
    May 12, 2026
    Manufacturer
    BLUEWIND MEDICAL LTD
    Product Code
    QXM
    UDI-DI
    07290017912011
    PMA / PMN Number
    K240037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLUEWIND HAS ADOPTED MORE STRINGENT REPORTING CRITERIA FOR IMPLANT-RELATED COMPLAINTS STARTING APRIL 24, 2026. A RETROSPECTIVE REVIEW OF TWO YEARS OF COMPLAINT DATA, COVERING THE PERIOD FROM MARCH 1, 2024 TO MARCH 1, 2026, WAS PERFORMED. A TOTAL OF 543 PATIENT CASES WERE REEVALUATED. OF THESE, 68 CASES INVOLVED PATIENT INFECTION, PAIN, WOUND HEALING ISSUES, IMPLANT FAILURE, OR SURGICAL COMPLICATIONS. THESE 68 CASES WERE REASSESSED AGAINST THE UPDATED REPORTING CRITERIA FOR IMPLANT-RELATED COMPLAINTS, AND FOUR COMPLAINTS WERE DETERMINED TO BE REPORTABLE UNDER THE NEW CRITERIA. COMPLAINT 00514 IS ONE OF FOUR REPORTABLE CASES.

    Description of Event or Problem · 0

    THE PATIENT WAS EXPERIENCING SEVERE PAIN AT THE IMPLANT SITE AND REQUESTED EXPLANTATION OF THE DEVICE. THE PATIENT WAS ALSO DIAGNOSED WITH SEVERE VENOUS INSUFFICIENCY AND WAS LIKELY NOT AN IDEAL CANDIDATE FOR REVI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435297 REVI SYSTEM IMPLANTED TIBIAL ELECTRICAL URINARY, PRODUCT CODE: QXM QXM BLUEWIND MEDICAL LTD MA-1007-0600_US_CM 07290017912011

    Patients

    Seq Age Sex Outcome Treatment
    1