BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN SYSTEM

    MDR report key: 19116773 · Received April 15, 2024

    Report

    Report Number
    MW5153885
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    February 26, 2024
    Report Date
    April 11, 2024
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVED A SEE DOCTOR ALARM FROM THE GUARDIAN IMPLANT ON (B)(6) 2024. AT DOCTOR¿S OFFICE ON (B)(6) 2024 IT WAS CONFIRMED THAT THE DEVICE WAS NO LONGER ABLE TO COMMUNICATE WITH THE PROGRAMMER AND WAS LIKELY AT EOS DUE TO BATTERY DEPLETION. DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2024. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS PROBLEM. THE EXPLANTED DEVICE WAS SENT TO THE MANUFACTURER FOR FORENSIC ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498900 GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 120120V0209530000035

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male