BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM

    MDR report key: 25022376 · Received April 28, 2026

    Report

    Report Number
    3012309950-2026-00021
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 28, 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

    Description of Event or Problem · 0

    THE PATIENT REPORTED SIGNIFICANT PAIN ASSOCIATED WITH SWALLOWING AND SPEAKING FOLLOWING DEVICE IMPLANTATION ON (B)(6) 2025. THE PATIENT DID NOT WANT THE DEVICE SETTINGS/STIMULATIONS ADJUSTED, PER THE PATIENTS REQUEST, THE DEVICE WAS EXPLANTED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349067 VIVISTIM® PAIRED VNS¿ SYSTEM VIVISTIM QPY MOBIA MEDICAL, INC 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| O