BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 20269180 · Received September 19, 2024

    Report

    Report Number
    MW5159805
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 17, 2024
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUARDIAN SYSTEM IMPLANTABLE DEVICE REACHED EARLY EOS AND WAS EXPLANTED AND REPLACED. THE BATTERY WAS DESIGNED TO LAST 6 YEARS AND REACHED EOS ~4 YEARS AND 207 DAYS AFTER ACTIVATION. THE DEVICE WAS EXPLANTED AND WILL BE DECONTAMINATED AND RETURNED FOR FORENSIC INVESTIGATION. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309108 THE GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 120120V0209530000031

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other