BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE GUARDIAN SYSTEM

    MDR report key: 20127608 · Received August 30, 2024

    Report

    Report Number
    MW5159172
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    May 13, 2024
    Report Date
    August 27, 2024
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A GUARDIAN ON (B)(6) 2022. PATIENT REPORTED TO THE HOSPITAL WITH SYMPTOMS ON (B)(6) 2024 AND AT THAT TIME THE GUARDIAN IMPLANT COULD NOT BE COMMUNICATED WITH. THE PATIENT HAS BEEN DIAGNOSED WITH LUNG CANCER. HE HAS DECIDED TO NOT HAVE THE DEVICE EXPLANTED OR REPLACED DUE TO THE CANCER DIAGNOSIS. IF THE DEVICE IS EXPLANTED IN THE FUTURE, IT WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056231 THE GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 011221V0210150000039

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male