BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVERTIX MEDICAL INC. GUARDIAN SYSTEM

    MDR report key: 17585080 · Received August 18, 2023

    Report

    Report Number
    MW5144773
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    May 5, 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
    501
    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 ON (B)(6) 2023. AT THAT APPOINTMENT THE DEVICE COULD NO LONGER RELIABLY COMMUNICATE WITH THE PROGRAMMER. THE PHYSICIAN WAS NOTIFIED AND DISCUSSED THE PROBLEM WITH THE PATIENT AS WELL AS THE OPTIONS AVAILABLE TO THEM. THE PATIENT AND PATIENT'S HUSBAND INDICATED THEY WILL MEET AGAIN ON (B)(6) 2023, TO INDICATE THEIR DECISION AT THAT TIME. THIS PROBLEM WILL BE INVESTIGATED WHEN THE DEVICE IS RETURNED TO AVERTIX AFTER EXPLANT. THE FOLLOWING ISSUE WAS CREATED IN THE QMS OF AVERTIX FOR THIS PROBLEM: ISSUE 77 ISSUE 77 WAS ESCALATED TO A COMPLAINT FOR INVESTIGATION: COMPLAINT 55 COMPLAINT 55 WAS ASSIGNED TO CAPA FOR CORRECTIVE AND PREVENTIVE ACTION DETERMINATIONS: CAPA 12 THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EVENTS AS A RESULT OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483508 AVERTIX MEDICAL INC. GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 120120V0209530000031

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female