BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM

    MDR report key: 25262563 · Received May 22, 2026

    Report

    Report Number
    3012309950-2026-00024
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MOBIA MEDICAL, INC.
    Product Code
    QPY
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED ON (B)(6) 2024. AS PER THE EXPLANTING HOSPITAL, THE PATIENT WAS EXPLANTED DUE TO ANTICIPATED FUTURE NEED FOR MRI PROCEDURES AND STATED THAT THE DEVICE WAS NOT FUNCTIONING. THERE WERE NO REQUESTS FOR TROUBLESHOOTING OR EVALUATION OF ALLEGED DEVICE FUNCTIONALITY ISSUES WERE MADE BY THE PATIENT, CAREGIVER, OR HEALTHCARE PROVIDERS. MOBIA OFFERED ASSISTANCE IN IDENTIFYING A THERAPIST TO RESUME PAIRED VNS THERAPY; HOWEVER, THE PATIENT DECLINED FURTHER THERAPY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179299 VIVISTIM® PAIRED VNS¿ SYSTEM VIVISTIM QPY MOBIA MEDICAL, INC. 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other