BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVERTIX MEDICAL INC. GUARDIAN SYSTEM

    MDR report key: 17585300 · Received August 18, 2023

    Report

    Report Number
    MW5144780
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    March 13, 2023
    Report Date
    August 15, 2023
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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. THE PHYSICIAN WAS NOTIFIED AND DISCUSSED THE PROBLEM WITH THE PATIENT AND INDICATED THAT THE DEVICE SHOULD BE EXPLANTED SO THAT THE ROOT CAUSE OF THE PROBLEM COULD BE IDENTIFIED. THE PATIENT AGREED TO THE EXPLANT AND THE DEVICE WAS EXPLANTED ON (B)(6) 2023. THE DEVICE WAS SENT TO DECONTAMINATION FACILITY AND WAS RECEIVED AT AVERTIX MEDICAL INC. ON APRIL 13, 2023. AN INVESTIGATION WAS INITIATED TO DETERMINE THE ROOT CAUSE OF THE PROBLEM. THE FOLLOWING ISSUE WAS CREATED IN THE QMS OF AVERTIX FOR THIS PROBLEM: ISSUE 67 ISSUE 67 WAS ESCALATED TO A COMPLAINT FOR INVESTIGATION: COMPLAINT 48 COMPLAINT 48 WAS ASSIGNED TO CAPA FOR CORRECTIVE AND PREVENTIVE ACTION DETERMINATIONS: CAPA 12 THE PATIENT EXPERIENCED NO ADVERSE EVENTS ASSOCIATED WITH THIS PROBLEM OTHER THAN THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483515 AVERTIX MEDICAL INC. GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 020120V0209530000031

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male