BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 22044397 · Received May 19, 2025

    Report

    Report Number
    3017374019-2025-00041
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    May 5, 2025
    Report Date
    May 19, 2025
    Manufacturer
    AVERTIX MEDICAL INC
    Product Code
    QBI
    PMA / PMN Number
    PMA150009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT PATIENT VISIT THE PROGRAMMER COULD NTO COMMUNICATE WITH THE IMPLANTABLE DEVICE. POSSIBLY A PREMATURE BATTERY DEPLETION OF THE AMSG3-E CARDIAC IMPLANTABLE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132707 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC AMSG3-E 121720V0209530000037

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male