BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24324539 · Received February 12, 2026

    Report

    Report Number
    3012309950-2026-00005
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    September 5, 2025
    Report Date
    February 12, 2026
    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

    PATIENT WAS IMPLANTED ON (B)(6) 2025. PATIENT REPORTED SWELLING AND BRUISING AT IPG IMPLANT SITE. PATIENT FOLLOWED UP WITH SURGEON AND PATIENT WAS EXPLANTED DUE TO INFECTION. MICROTRANSPONDER WAS NOT PRESENT FOR THE EXPLANT AND WAS NOT NOTIFIED UNTIL AFTER THE EXPLANT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387094 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM SYSTEM QPY MICROTRANSPONDER, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other