BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20481590 · Received October 18, 2024

    Report

    Report Number
    3012309950-2024-00005
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    September 6, 2024
    Report Date
    October 17, 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

    PATIENT REPORTED DISCOMFORT AT THE IPG IMPLANT SITE. PATIENT CONSULTED WITH IMPLANTING PHYSICIAN. DUE TO THE PATIENT HAVING A LOW BODY MASS, THE PHYSICIAN RECOMMENDED A CORRECTIVE SURGERY TO IMPLANT THE IPG DEEPER IN THE PATIENT TO PREVENT RUBBING ON THE SKIN AND ALLEVIATE THE DISCOMFORT. THE VIVISTIM SYSTEM REMAINED IMPLANTED. PATIENT REPORTS POST PROCEDURE THAT THE PAIN HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230778 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention