BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21819344 · Received April 10, 2025

    Report

    Report Number
    3017374019-2025-00003
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    December 1, 2022
    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

    Description of Event or Problem · 0

    THE PATIENT HAD A GUARDIAN IMPLANTED ON (B)(6) 2022 AND DUE TO A POCKET INFECTION, HAD THE GUARDIAN EXPLANTED 0N (B)(6) 2022. WE WERE NOT NOTIFIED OF THE EXPLANT UNTIL (B)(6) 2023. THIS MDR IS BEING FILED RETROACTIVELY AS A RESULT OF AN OBSERVATION GENERATED AT AN FDA INSPECTION PERFORMED 19-FEB-2025 THROUGH 11-MAR-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911758 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC AMSG3-E

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R