BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19243496 · Received May 3, 2024

    Report

    Report Number
    3012309950-2024-00002
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 3, 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

    PAIN HAD SYSTEM EXPLANTED DUE TO PAIN NEAR IPG POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771840 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other