BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN SYSTEM

    MDR report key: 22809613 · Received August 14, 2025

    Report

    Report Number
    3017374019-2025-00051
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 14, 2025
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    PMA / PMN Number
    PMA150009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT VISIT DUE TO END OF BATTERY LIFE SEE DOCTOR ALARM. THE IMPLANT HAD REACHED END OF LIFE AND COULD NOT BE COMMUNICATED WITH. NEEDS TO BE SCHEDULED FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782526 GUARDIAN SYSTEM THE GUARDIAN SYSTEM QBI AVERTIX MEDICAL INC. AMSG3-E

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female