BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 23045600 · Received September 12, 2025

    Report

    Report Number
    3012239564-2025-00015
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 12, 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 REQUESTED THE DEVICE BE EXPLANTED "DUE TO NOT HAVING RELIEF", AND "THE PATIENT WOULD FEEL TINGLING ON TOP OF HER FOOT AND IN HER ACHILLES AREA" BUT WAS "VERY NON-COMPLIANT ACCORDING TO HER DASHBOARD DATA".

    Description of Event or Problem · 0

    WHILE THE FCS WAS AT THE HOSPITAL FOR ANOTHER IMPLANT, THE PHYSICIAN SAYS SHE IS EXPLANTING REVI FOR THIS PATIENT AS THE NEXT CASE. THE FCS WAS ABLE TO COLLECT THE DEVICE AND BY RMA AND BIOHAZARD KIT USED TO SEND IT BACK. THIS WAS THE PATIENT'S DECISION DUE TO NOT HAVING RELIEF. HER EXTREME EDEMA IN BOTH LEGS MADE IT VERY DIFFICULT TO PROPERLY DIRECT STIM, AND THE PATIENT WOULD FEEL TINGLING ON TOP OF HER FOOT AND IN HER ACHILLES AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673812 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 NA Female Hospitalization