BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)

    MDR report key: 24811055 · Received April 7, 2026

    Report

    Report Number
    3012309950-2026-00016
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    December 8, 2025
    Report Date
    April 7, 2026
    Manufacturer
    MOBIA MEDICAL, INC.
    Product Code
    QPY
    UDI-DI
    10810041430028
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED BASED ON DISCUSSIONS WITH THE FDA DURING AN ONSITE INSPECTION. DEVICE LOG FILES WERE OBTAINED AND REVIEWED FOR THE PERIOD OF 12/03/2025 THROUGH 03/20/2026, INCLUDING THE DATE OF THE REPORTED EVENT. ANALYSIS OF THE IPG LOG FILES INDICATED THAT THE PATIENT PARTICIPATED IN MULTIPLE IN-CLINIC THERAPY SESSIONS AS WELL AS AT-HOME THERAPY SESSIONS INITIATED USING THE MAGNET. THE LOG DATA CONFIRM THAT THE IPG WAS PROGRAMMED WITHIN THE MANUFACTURER'S RECOMMENDED SETTINGS AND FUNCTIONED AS INTENDED BEFORE, DURING, AND AFTER THE EVENT. FOLLOWING THE EVENT, THE PATIENT HAS CONTINUED USE OF THE VIVISTIM SYSTEM IN BOTH IN-CLINIC AND AT-HOME SETTINGS WITHOUT THE USE OF EXTERNAL ELECTRICAL STIMULATION AND WITHOUT RECURRENCE OF SIMILAR ADVERSE EVENTS. AT THE TIME OF THE EVENT, EXTERNAL ELECTRODES WERE REPORTEDLY PLACED AT THE BASE OF THE THUMB. NO DEVICE MALFUNCTION WAS IDENTIFIED IN THE LOG FILES OR OTHERWISE REPORTED TO THE COMPANY. BASED ON THE AVAILABLE INFORMATION, VNS THERAPY IS UNLIKELY TO HAVE CAUSED THE LOSS OF CONSCIOUSNESS GIVEN THE LOW STIMULATION SETTINGS AND SHORT STIMULATION DURATION.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED ON (B)(6) 2025. DURING THE THIRD OCCUPATIONAL THERAPY SESSION, WHICH REPORTEDLY INVOLVED THE COMBINED USE OF EXTERNAL ELECTRICAL STIMULATION AT INCREASED SETTINGS AND THE VIVISTIM SYSTEM, THE PATIENT EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT. THE PATIENT REPORTED EXPERIENCING AN INTENSE ELECTRICAL SENSATION ORIGINATING IN THE THUMB DURING THE COMBINED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482025 VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM SYSTEM QPY MOBIA MEDICAL, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other| H