BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 533698 · Received June 15, 2004

    Report

    Report Number
    533698
    Event Type
    Malfunction
    Date Received
    June 15, 2004
    Date of Event
    January 1, 2004
    Report Date
    June 14, 2004
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPARENT FAILURE OF MEDTRONIC PACER TO CAPTURE. UNIT REPLACED WITH APPROPRIATE, FUNCTIONALITY NOTED AFTERWARDS. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PACER W/RV LEAD DXY MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT DEVICE 7230CX *
    2 * PACER W/ RV LEAD DTB NEDTRONIC, INC.; CARDIAC RHYTHM MANAGEMENT R. VENT. LEAD TD *

    Patients

    Seq Age Sex Outcome Treatment
    1 *