BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM

    MDR report key: 25186469 · Received May 15, 2026

    Report

    Report Number
    3012309950-2026-00023
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 15, 2026
    Manufacturer
    MOBIA MEDICAL, INC.
    Product Code
    QPY
    UDI-DI
    10810041430066
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    DURING THE INITIAL IMPLANTATION PROCEDURE FOR THE VIVISTIM SYSTEM, THE SURGEON IDENTIFIED ANATOMICAL LIMITATIONS INVOLVING THE PATIENT'S VAGUS NERVE THAT PREVENTED SAFE PLACEMENT OF THE HELICAL LEAD. THE VAGUS NERVE WAS REPORTED TO BE TOO SMALL FOR THE 2 MM HELICAL LEAD AND CONTAINED MULTIPLE BRANCHES THAT INTERFERED WITH LEAD PLACEMENT. THE IMPLANTING PHYSICIAN CONSULTED A COLLEAGUE INTRAOPERATIVELY TO CONFIRM IDENTIFICATION OF THE VAGUS NERVE, AND THE COLLEAGUE CONCURRED WITH THE ASSESSMENT. DUE TO THE PATIENT'S ANATOMY, THE IMPLANT PROCEDURE WAS ABORTED AND THE DEVICE WAS NOT IMPLANTED. NO DEVICE MALFUNCTION WAS IDENTIFIED. NO INJURY TO THE PATIENT WAS REPORTED AND THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION RELATED TO THE EVENT. THE EVENT IS CONSIDERED RELATED TO PATIENT ANATOMY RATHER THAN DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442027 VIVISTIM® PAIRED VNS¿ SYSTEM VIVISTIM QPY MOBIA MEDICAL, INC. 3000 10810041430066

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Other