BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 20127627 · Received August 30, 2024

    Report

    Report Number
    MW5159173
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    May 8, 2024
    Report Date
    August 27, 2024
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH THE GUARDIAN SYSTEM ON (B)(6) 2022. PATIENT CAME IN FOR A SCHEDULED FOLLOW-UP VISIT ON (B)(6) 2024 AND THE PROGRAMMER COULD NOT COMMUNICATE RELIABLY WITH THE IMPLANT. THE DOCTOR DISCUSSED THE PROBLEM WITH THE PATIENT AND IT WAS DECIDED TO EXPLANT THE DEVICE AND REPLACE IT WITH A NEW DEVICE. THIS WAS DONE ON (B)(6) 2024. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE BATTERY WAS RETURNED TO (B)(4) FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079728 THE GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 011121V0210150000039

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female