BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23054224 · Received September 15, 2025

    Report

    Report Number
    3012309950-2025-00004
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MICROTRANSPONDER, INC.
    Product Code
    QPY
    UDI-DI
    10810041430080
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE ORIGINAL IMPLANTATION OF THE VIVISTIM SYSTEM OCCURRED ON (B)(6) 2024 (THAT SURGEON IS NO LONGER AT THAT HOSPITAL). ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION OF THE NECK INCISION AT THE LEAD INSERTION SITE BY A DIFFERENT SURGEON AT A DIFFERENT HOSPITAL THAT HAS PREVIOUSLY IMPLANTED THE VIVISTIM SYSTEM WITH OTHER PATIENTS. MICROTRANSPONDER INC. (MTI) INCLUDES FOUR TIE-DOWNS IN THE LEAD PACKAGING TO SECURE THE LEAD IN PLACE. IT WAS REPORTED, THAT ONE OF THE TIE-DOWNS APPEARED TO BE PUSHING AGAINST THE SURFACE OF THE SKIN, SHOWING A SMALL BUMP VISIBLE TO THE PATIENT. THE SURGEON REOPENED THE INCISION AND REMOVED THE TIE-DOWN. SUBSEQUENT TESTING OF BOTH THE LEAD AND THE IMPLANTABLE PULSE GENERATOR (IPG) CONFIRMED THAT THEY WERE FUNCTIONING AS INTENDED. THE TIE DOWN WAS DISPOSED OF AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955198 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 3000 10810041430080

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other