BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVERTIX MEDICAL INC. GUARDIAN SYSTEM

    MDR report key: 17737296 · Received September 12, 2023

    Report

    Report Number
    MW5145578
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 8, 2023
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PREMATURE BATTERY DEPLETION OF THE PATIENTS GUARDIAN SYSTEM AMSG3-E IMD. THE INITIAL ISSUE OCCURRED (B)(6), 2023 WHEN THE PATIENT REPORTED TO HER DOCTOR WITH A SEE DOCTOR ALERT FROM THE DEVICE. AT THE DOCTOR'S OFFICE THE IMPLANT WAS INTERROGATED AND IT WAS DETERMINED THAT THE DEVICE HAD EXPERIENCED A DEVICE RESET. HOWEVER, THE DEVICE COULD NO LONGER COMMUNICATE WITH THE PHYSICIAN PROGRAMMER AFTERWARDS. THE PHYSICIAN WAS MADE AWARE OF THE ISSUE AND THE PHYSICIAN SPOKE TO THE PATIENT AT THAT TIME AND INDICATED THE OPTIONS AVAILABLE TO HER: EXPLANT AND REPLACEMENT, EXPLANT WITHOUT REPLACEMENT, OR LEAVE IN PLACE. THE PATIENT HAS NOT YET DECIDED WHAT OPTION THEY WILL SELECT. THE FOLLOWING ISSUE WAS CREATED IN THE QMS OF AVERTIX FOR THIS PROBLEM: ISSUE 79, ISSUE 79 WAS ESCALATED TO A COMPLAINT FOR INVESTIGATION: COMPLAINT (B)(4); COMPLAINT (B)(4) WAS ASSIGNED TO CAPA FOR CORRECTIVE AND PREVENTIVE ACTION DETERMINATIONS: CAPA 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252253 AVERTIX MEDICAL INC. GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 011121V0210150000038

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female