BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)

    MDR report key: 24772192 · Received April 2, 2026

    Report

    Report Number
    3012309950-2026-00018
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MOBIA MEDICAL, INC.
    Product Code
    QPY
    UDI-DI
    10810041430028
    PMA / PMN Number
    P210007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED ON (B)(6) 2026. DURING THE FIRST IN CLINIC THERAPY SESSION ON (B)(6) 2026, THE PATIENT'S IPG INDICATED THAT THE "DEVICE WAS IN ERI (EARLY REPLACEMENT INDICATOR)". LOG FILES AND MANUFACTURING RECORDS WERE REVIEWED FOR THE IPG S/N (B)(6). THE DEVICE IS FUNCTIONING AS EXPECTED AND ABLE TO PROVIDE THERAPY. THE DEVICE WAS RESET AND REPROGRAMMED ON (B)(6) 2026. THE ERI NOTIFICATION MESSAGE DID NOT TRIGGER AFTER THE RESET. WHILE THERE IS NO INJURY TO THE PATIENT OR MEDICAL/SURGICAL INTERVENTION REPORTED AT THIS TIME, IF THE MALFUNCTION WERE TO RECUR THE PATIENT COULD HAVE THEIR DEVICE ERRONEOUSLY REPLACED EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64967 VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MOBIA MEDICAL, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male