BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 22809614 · Received August 14, 2025

    Report

    Report Number
    3017374019-2025-00052
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 15, 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 HAD A PREMATURE BATTERY ED OF LIFE OF THIER GUARDIAN SYSTEM IMPLANTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782527 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC. AMSG3-E

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male