BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)

    MDR report key: 22440066 · Received July 8, 2025

    Report

    Report Number
    3012309950-2025-00002
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 8, 2025
    Manufacturer
    MICROTRANSPONDER, INC.
    Product Code
    QPY
    UDI-DI
    10810041430028
    PMA / PMN Number
    210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON (B)(6) 2025. DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE NEUROSURGEON OBSERVED OOZING AT THE SURGICAL SITE. ON (B)(6) 2025, THE PATIENT UNDERWENT A WOUND WASHOUT. AN ANTIBIOTIC SLEEVE WAS USED, AND THE IPG WAS PLACED INSIDE THE SLEEVE BEFORE BEING POSITIONED BACK IN THE ORIGINAL POCKET. THE DEVICE WAS TESTED AFTER THE IPG WAS PLACED BACK IN THE POCKET, IMPEDANCE WAS CHECKED AND MEASURED AT 2000 OHMS. THE DEVICE IS PERFORMING AS EXPECTED. SINCE THE DEVICE REMAINS IMPLANTED, THE IPG IS NOT AVAILABLE FOR EVALUATION BY MICROTRANSPONDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843431 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention