BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23705509 · Received December 3, 2025

    Report

    Report Number
    3012309950-2025-00006
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    MICROTRANSPONDER, INC.
    Product Code
    QPY
    UDI-DI
    10810041430028
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH THE VIVISTIM SYSTEM ON (B)(6) 2024. THE PATIENT REPORTED DISCOMFORT NEAR THE IPG SURGICAL SITE WHEN LYING DOWN AND STATED THAT SHE COULD FEEL THE IPG MOVING. THE PATIENT ELECTED TO HAVE THE IPG AND LEAD EXPLANTED ON (B)(6) 2025. A SMALL DISTAL PORTION OF THE LEAD WAS LEFT IN PLACE; THE PHYSICIAN CONFIRMED THAT LESS THAN 5 CM OF LEAD REMAINED, AS RECOMMENDED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2856647 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 3000 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other