BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834873 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00005
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 13, 2023
    Report Date
    April 12, 2025
    Manufacturer
    AVERTIX MEDICAL INC.
    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 OF 25 DEVICES IMPACTED. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER AVERTIX PERFORMED A VOLUNTARY CORRECTION AND WAS INSPECTED ON FEBRUARY 19TH THRU MARCH 11, 2025.

    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 AND MADE AN APPOINTMENT TO SEE THE CARDIOLOGIST ON THE FOLLOWING DAY. AT THAT APPOINTMENT THE DEVICE WAS INTERROGATED AND IT WAS IDENTIFIED THAT A DEVICE RESET HAD OCCURRED. FURTHER EVALUATION INDICATED THAT THE DEVICE COULD NO LONGER RELIABLY COMMUNICATE WITH THE PROGRAMMER. THIS EVENT WAS ONE OF 25 PREMATURE BATTERY DEPLETION EVENTS IDENTIFIED. ALL WERE DUE TO A QC PROBLEM AT THE BATTERY MANUFACTURER. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII DEVISIONS OF THE FDA AND AN INSPECTION PERFORMED FEBRUARY 19, 2025 THRU MARCH 11, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022829 THE GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC. AMSG3-E 120120V0209530000031

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention