BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM

    MDR report key: 24841017 · Received April 10, 2026

    Report

    Report Number
    3012309950-2026-00020
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 10, 2026
    Manufacturer
    MOBIA MEDICAL, 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 IMPLANTED ON (B)(6) 2023. THE PATIENT ELECTED DEVICE EXPLANTATION DUE TO THE PATIENT REPORTING PLATEAU IN IMPROVEMENT. THE IPG WAS EXPLANTED, AND THE LEAD WAS CUT AT THE BIFURCATION. THE EXPLANT PROCEDURE OCCURRED ON (B)(6) 2026. THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383569 VIVISTIM® PAIRED VNS¿ SYSTEM VIVISTIM® SYSTEM QPY MOBIA MEDICAL, INC 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| O