BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23052974 · Received September 15, 2025

    Report

    Report Number
    3012309950-2025-00003
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MICROTRANSPONDER, INC.
    Product Code
    QPY
    UDI-DI
    10810041430028
    PMA / PMN Number
    P210007
    Product Problem
    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 ON (B)(6) 2024. DURING A FOLLOW UP VISIT, COMMUNICATION WITH THE IMPLANTABLE DEVICE COULD NOT BE ESTABLISHED. STANDARD TROUBLESHOOTING PROCEDURES WERE PERFORMED BUT WERE UNSUCCESSFUL. THE LAST CONFIRMED COMMUNICATION WITH THE DEVICE OCCURRED ON (B)(6) 2024. THE PATIENT UNDERWENT REPLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG) ON (B)(6) 2025, WHILE THE ORIGINAL LEAD REMAINED IN PLACE. FUNCTIONAL TESTING OF THE NEWLY IMPLANTED IPG AND THE LEAD WERE COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE PERFORMED AS EXPECTED. THE ORIGINAL IPG WAS RETURNED TO MICROTRANSPONDER FOR EVALUATION, WHERE IT WAS CONFIRMED THAT COMMUNICATION WITH THE DEVICE COULD NOT BE ESTABLISHED. THE IPG WAS FORWARDED TO THE CONTRACT MANUFACTURER FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760256 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other