BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVERTIX MEDICAL INC. GUARDIAN SYSTEM

    MDR report key: 17585032 · Received August 18, 2023

    Report

    Report Number
    MW5144771
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 12, 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. THE PATIENT RETURNED TO SEE THE DOCTOR AND AT THAT APPOINTMENT THE DEVICE COULD NO LONGER RELIABLY COMMUNICATE WITH THE PROGRAMMER. THE PHYSICIAN DISCUSSED THE PROBLEM WITH THE PATIENT AS WELL AS THE OPTIONS AVAILABLE TO THEM. THE PATIENT AND PATIENT'S HUSBAND INDICATED THEY WILL DECIDE WHETHER OR NOT TO EXPLANT THE DEVICE AND LET THE DOCTOR KNOW. THIS PROBLEM WILL BE INVESTIGATED IF THE DEVICE IS RETURNED TO AVERTIX PROVIDED THE PATIENT AGREES TO AN EXPLANT. THE FOLLOWING ISSUE WAS CREATED IN THE QMS OF AVERTIX FOR THIS PROBLEM: ISSUE 76 ISSUE 76 WAS ESCALATED TO A COMPLAINT FOR INVESTIGATION: COMPLAINT 54 COMPLAINT 54 WAS ASSIGNED TO CAPA FOR CORRECTIVE AND PREVENTIVE ACTION DETERMINATIONS: CAPA 12 THE PATIENT EXPERIENCED NO ADVERSE EVENTS DUE TO THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483506 AVERTIX MEDICAL INC. GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 011121V0210150000038

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male