BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVI SYSTEM

    MDR report key: 22869143 · Received August 21, 2025

    Report

    Report Number
    3012239564-2025-00012
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 21, 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

    DR. (B)(6) HAS ASSURED THE PATIENT THAT IT IS PART OF THE HEALING PROCESS. PATIENT WILL UPDATE DR. (B)(6) OF ANY CHANGES. PATIENT REPORTS NO MORE PAIN AFTER BEING PRESCRIBED MEDS BY HCP, THE IMPLANT ACTIVATION IS SCHEDULED FOR (B)(6).

    Description of Event or Problem · 0

    PATIENT CALLED AND REPORTED SHARP BURNING PAIN IN ANKLE NEAR INCISION SITE. SHE SAID THE PAIN STARTED LAST NIGHT, (B)(6) 2025 AROUND 9:30PM AND SHE TOOK HER SLEEPING PILLS THAT HELPED HER GO TO BED. PAIN WOKE HER UP AT 3AM AND SHE HAD TO TAKE OTC PAIN MEDICATION TO GO BACK TO BED. SHE DESCRIBES THE PAIN TO BE AN 8 OUT OF 10 WHEN PRESENT. TODAY THE PAIN HAS BEEN OFF AND ON AND NOT TRIGGERED BY ANY CERTAIN ACTIVITY. SHE DID HAVE AN APPT WITH DR. (B)(6) AND SHE SAID THE INCISION LOOKS GOOD AND NOT SURE WHAT MAY BE CAUSING PAIN. SHE WAS PRESCRIBED GABAPENTIN FOR PAIN WHICH SHE WILL TAKE TODAY. SHE WAS IMPLANTED ON (B)(6) AND YET TO BE ACTIVATED. (B)(6) ADVISED PATIENT TO FOLLOW DR. (B)(6) INSTRUCTIONS OF RESTING, ELEVATING LEG AND TAKING PRESCRIBED MEDICATION OF GABAPENTIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182655 REVI SYSTEM IMPLANTED TIBIAL ELECTRICAL URINARY CONTINENCE DEVICE QXM BLUEWIND MEDICAL LTD KA-9000-0001_US_CM 2401101 07290017912226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other