BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM

    MDR report key: 25310843 · Received May 27, 2026

    Report

    Report Number
    3012309950-2026-00025
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MOBIA MEDICAL, INC
    Product Code
    QPY
    UDI-DI
    10810041430028
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED IPG WAS EVALUATED AND NO FUNCTIONAL ISSUES WERE IDENTIFIED DURING PERFORMANCE TESTING. LOG FILES SHOW INITIAL PROGRAMMING TO EXPECTED SETTINGS, WHICH WERE UNCHANGED LEADING UP TO EXPLANT DATE. PATIENT ATTENDED OVER 30 IN-CLINIC THERAPY SESSIONS AND SELF-ACTIVATED THE DEVICE OVER 300 TIMES BETWEEN INITIAL IMPLANT AND EXPLANT PROCEDURES. NO PROBLEMS IN THE MANUFACTURE OR USE OF THE DEVICE HAVE BEEN IDENTIFIED.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON (B)(6) 2025 AND BEGAN THERAPY PROTOCOL ON (B)(6) 2026. THE PATIENT LATER SUBSEQUENTLY REPORTED EXPERIENCING CHEST SHOCKING SENSATIONS WHILE THE DEVICE WAS NOT ACTIVELY DELIVERING STIMULATION. THE IMPLANTING PHYSICIAN REPLACED THE IPG ON (B)(6) 2026, AND THE ORIGINALLY IMPLANTED LEAD WAS NOT REPLACED. MOBIA MEDICAL PERSONNEL WERE NOT PRESENT DURING THE PROCEDURE. PATIENT DEVELOPED LEFT-SIDED WEAKNESS APPROXIMATELY TWO WEEKS AFTER THE REPLACEMENT PROCEDURE ON (B)(6) 2026, WAS IN HOSPITAL FOR TWO DAYS, AND DISCHARGED TO OUT-PATIENT REHAB; CT IMAGING WAS REPORTEDLY INCONCLUSIVE AS TO CAUSE. THE REPLACEMENT IPG WAS TURNED ON PER PHYSICIAN CLEARANCE ON (B)(6) 2026 TO SUPPORT AT HOME USE OF THE DEVICE. THE EXPLANTED IPG WAS RETURNED TO MOBIA MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294855 VIVISTIM® PAIRED VNS¿ SYSTEM VIVISTIM QPY MOBIA MEDICAL, INC 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| O