BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834884 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00007
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    July 12, 2023
    Report Date
    April 12, 2025
    Manufacturer
    AVERTIX MEDICAL
    Product Code
    QBI
    PMA / PMN Number
    P150009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS ONE FO 25 IMPACTED DEVICES. A VOLUNTARY CORRECTIVE FILED ACTION WAS PERFORMED YEARS AGO. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A GUARDIAN DEVICE ON (B)(6) 2022. PATIENT WAS ALERTED BY THE GUARDIAN SYSTEM VIA A SEE DOCTOR ALERT ON (B)(6) 2023. THE PATIENT RETURNED TO SEE THE DOCTOR AND AT THAT APPOINTMENT THE DEVICE COULD NO LONGER RELIABLY COMMUNICATE WITH THE PROGRAMMER. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER AN INSPECTION PERFORMED ON FEBRUARY 19 THRU MARCH 11, 2025. AVERTIX PERFORMED A VOLUNTARY CORRECTION A COUPLE OF YEARS AGO FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007192 THE GUARDIAN SYSTEM THE GUARDIAN QBI AVERTIX MEDICAL AMSG3-E 011121V0210150000038

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention