BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)

    MDR report key: 24772191 · Received April 2, 2026

    Report

    Report Number
    3012309950-2026-00019
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 2, 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

    PATIENT WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT EXPERIENCED NEUROLOGICAL SYMPTOMS INCLUDING SLURRED SPEECH, FACIAL DROOPING, COUGHING WITH STIMULATION, GENERALIZED WEAKNESS, IMPAIRED MOBILITY, AND MULTIPLE FALLS REQUIRING EMS TRANSPORT AND HOSPITAL ADMISSION. ER EVALUATION REPORTEDLY INCLUDED CT IMAGING AND LABS, WITH DEHYDRATION NOTED PER SURROGATE. THE PATIENT SELF-DISCHARGED. NO DEVICE MALFUNCTION WAS CONFIRMED AT THE TIME OF REPORT. DEVICE EVALUATION SHOWED NORMAL IMPEDANCE AND A NORMAL INCISION SITE. THE PATIENT REPORTED TRANSIENT COUGHING WITH STIMULATION BUT WAS UNSURE IF THIS WAS NEW. THE PATIENT AGREED TO TURN THE DEVICE OFF PENDING NEUROLOGICAL EVALUATION. MRI DOCUMENTATION WAS PROVIDED. FOLLOW-UP WITH A NEUROLOGIST IS SCHEDULED FOR ON (B)(6) 2026. DEVICE REMAINS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64966 VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MOBIA MEDICAL, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other| H