BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21817195 · Received April 10, 2025

    Report

    Report Number
    3017374019-2025-00001
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    January 1, 2024
    Report Date
    April 11, 2025
    Manufacturer
    AVERTIX MEDICAL INC
    Product Code
    QBI
    PMA / PMN Number
    P150009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING RETROACTIVELY SUBMITTED DUE TO AN FDA INSPECTION OBSERVATION. THE EVENT HAPPENED SOME YEARS AGO. THE FDA INSPECTION HAPPENED FEBRUARY 19 THRU MARCH 11, 2025.

    Description of Event or Problem · 0

    THE GUARDIAN SYSTEM MD (SERIAL NUMBER: (B)(6)) WAS INITIALLY IMPLANTED ON (B)(6) 2021. THE PATIENT WAS ADMITTED TO (B)(6) AT AN UNKNOWN DATE WITH BACTEREMIA AND HAD HIS CHEMOTHERAPY PORT REMOVED. TEE SHOWED LARGE VEGETATION ON THE RV LEAD WITHOUT EVIDENCE OF VEGETATION ON OTHER VALVES. THE PATIENT WAS THEN TRANSFERRED TO (B)(6) ON (B)(6) 2024 FOR FURTHER MANAGEMENT AND THE GUARDIAN SYSTEM WAS ULTIMATELY EXPLANTED ON (B)(6) 2024 AFTER RECEIVING THE PATIENT'S CONSENT. THERE WERE NO COMPLICATIONS FROM THIS EXPLANT PROCEDURE. THIS MDR IS BEING FILED RETROACTIVELY IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION PERFORMED FEBRUARY 18, 2025 THROUGHT MARCH 11, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471900 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC AMSG3-E

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H