BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18744182 · Received February 20, 2024

    Report

    Report Number
    3012309950-2024-00001
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 16, 2024
    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 IN (B)(6) 2023. OCTOBER, 2023, PATIENT REPORTED PAIN AT THE LOCATION OF THE IPG (S/N (B)(6) REGARDLESS OF THE STIMULATION BEING TURNED ON OR OFF. THE PATIENT MET WITH THE NEUROSURGEON NOVEMBER 2023 AND DISCUSSED OPTIONS. THE PATIENT REPORTED THAT THE PAIN SUBSIDES WHEN THE IPG IS "PUSHED UP". THE IPG WAS SURGICALLY REPOSITIONED ON (B)(6) 2024. POST PROCEDURE, THE PATIENT DENIES DISCOMFORT FROM THE DEVICE AND STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398025 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other