BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 20127591 · Received August 30, 2024

    Report

    Report Number
    MW5159171
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 27, 2024
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH GUARDIAN DEVICE ON (B)(6) 2022. PATIENT WAS ALERTED BY A SEE DOCTOR ALARM ON (B)(6) 2024. AT THAT APPOINTMENT THE DEVICE COULD NO LONGER RELIABLY COMMUNICATE WITH THE PROGRAMMER. THE PHYSICIAN WAS NOTIFIED AND HE DISCUSSED OPTIONS WITH THE PATIENT. THE PATIENT HAS NOT YET DECIDED WHETHER TO GET THE DEVICE REPLACED OR NOT. THE PROBLEM WILL BE FURTHER INVESTIGATED IF THE DEVICE IS EXPLANTED AND RETURNED. ISSUE 101 WAS CREATED IN THE AVERTIX QMS AND THAT ISSUE WAS PROMOTED TO COMPLAINT 70. ONCE THE INVESTIGATION IS COMPLETED COMPLAINT 70 WILL BE ADDED TO CAPA 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056230 THE GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 120120V0209530000037

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female