BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE XTDRMRI

    MDR report key: 20001630 · Received August 19, 2024

    Report

    Report Number
    MW5158594
    Event Type
    Malfunction
    Date Received
    August 19, 2024
    Report Date
    August 15, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I AM THE CHIEF MEDICAL OFFICER FOR THE TRANSPORTATION SECURITY ADMINISTRATION. I AM REPORTING LOSS OF CONNECTION BETWEEN MEDICAL DEVICES AND PATIENT'S IPHONE IN TWO OF OUR EMPLOYEES WHEN IN PROXIMITY (20 FEET IN EACH CASE) WITH OUR DETECTION DEVICES. BOTH ISSUES OCCURRED IN (B)(6) 2024 AT (B)(6) AIRPORT (CVG). ONE EMPLOYEE HAS A PACEMAKER (MEDTRONIC AZURE XTDRMRI MODEL W1DR01). THE OTHER EMPLOYEE HAS A CONTINUOUS GLUCOSE MONITOR (DEXCOM G7). THE DETECTION DEVICE IS NEW AND WAS INSTALLED IN (B)(6) 2024. IT IS A WALK-THROUGH "BODY SCANNER" ROHDE AND SCHWARZ QPS-201. I HAVE ENCOURAGED BOTH EMPLOYEES TO REPORT THE ISSUE TO FDA, AND HAVE THEIR PHYSICIANS DO THE SAME. REF REPORT: MW5158595.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372227 AZURE XTDRMRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. W1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown