BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20327657 · Received September 27, 2024

    Report

    Report Number
    3012309950-2024-00004
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2024
    Report Date
    September 27, 2024
    Manufacturer
    MICROTRANSPONDER, INC.
    Product Code
    QPY
    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 INITIALLY PART OF THE IDE CLINICAL STUDY AND NEEDED AN MRI. LEAD IMPEDANCE WAS GREATER THAN 12K OHMS. THE PATIENT DOES NOT FEEL STIMULATION. THE PATIENT IS NOT IN OT/PT. THE PATIENT IS NOT USING THE MAGNET. THE DEVICE WAS TURNED OFF. SINCE IMPEDANCE WAS HIGH, PER LABELING, DEVICE REQUIRED REMOVAL OR DEVICE AND LEAD REQUIRED REPLACEMENT SO THAT AN MRI COULD BE PERFORMED; PATIENT REQUESTED REMOVAL. THE IPG WAS EXPLANTED BUT THE ELECTRODE REMAINED IMPLANTED (LEAD WAS CLIPPED AND REMOVED SUCH THAT THE ELECTRODE CUFF WAS LEFT IN PLACE ON THE VAGUS NERVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491645 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention