BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)

    MDR report key: 24811085 · Received April 7, 2026

    Report

    Report Number
    3012309950-2026-00017
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    September 22, 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 REPORTED BASED ON DISCUSSIONS WITH THE FDA DURING AN ONSITE INSPECTION. DEVICE LOG FILES WERE OBTAINED AND REVIEWED FOR THE PERIOD FROM 08/20/2024 TO 10/28/2025, WITH THE REPORTED EVENT OCCURRING ON 09/22/2025. REVIEW OF THE LOG DATA INDICATES THAT THE VIVISTIM SYSTEM FUNCTIONED AS INTENDED BEFORE, DURING, AND AFTER THE REPORTED EVENT. PER PATIENT REQUEST, THE STIMULATION AMPLITUDE WAS INCREASED FROM 0.8 MA TO 0.9 MA, WITHIN RANGE OF TYPICAL SETTINGS. THE PATIENT'S MEDICAL HISTORY, LOG FILE DATA, CLINICAL LITERATURE, AND DEVICE UPDATED STIMULATION SETTINGS WERE EVALUATED. CONSIDERING THE ESTABLISHED SAFETY PROFILE OF VNS, THE LOW STIMULATION PARAMETERS, AND TYPE OF STROKE, THE PATIENT'S STROKE HISTORY, INCLUDING KNOWN PREDICTORS OF INCREASED SEIZURE RISK WITHIN ONE YEAR AS DESCRIBED IN PEER-REVIEWED LITERATURE, ALONG WITH CONFIRMED DEVICE PERFORMANCE AND CLINICAL CONTEXT, THERE IS NO OBJECTIVE EVIDENCE TO SUGGESTIT IS UNLIKELY THAT THE VIVISTIM SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEIZURE APPROXIMATELY 10 MINUTES AFTER INITIATING A MAGNET SESSION ON (B)(6) 2025. A MAGNET SESSION, WHICH IS A PATIENT-INITIATED THERAPY PERIOD DURING WHICH THE VIVISTIM SYSTEM DELIVERS VAGUS NERVE STIMULATION (VNS) PAIRED WITH REHABILITATION EXERCISES. THE PATIENT WAS HOSPITALIZED OVERNIGHT, DURING WHICH AN EEG AND CT SCAN WERE PERFORMED. THE PATIENT WAS STARTED ON KEPPRA AND DISCHARGED THE FOLLOWING DAY. THE PATIENT HAD USED THE VIVISTIM SYSTEM FOR APPROXIMATELY 13 MONTHS, WITH NO REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479184 VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MOBIA MEDICAL, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| O