BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 21834879 · Received April 14, 2025

    Report

    Report Number
    3017374019-2025-00006
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    April 20, 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 IS ONE OF 25 DEVICES THAT EXPERIENCED THIS PROBLEM. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER AN INSPECTION PERFORMED IN FEB 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 FOR (B)(6) 2023. 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 MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER AN INSPECTION WAS PERFORMED ON FEBRUARY 19TH THRU MARCH 11TH, 2025. AVERTIX PERFORMED A VOLUNTARY FIELD CORRECTION PREVIOUSLY TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007187 THE GUARDIAN SYSTEM THE GUARDIAN QBI AVERTIX MEDICAL INC AMSG3-E 011121V0210150000038

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention