BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE FIX

    MDR report key: 3212355 · Received July 8, 2013

    Report

    Report Number
    3212355
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 30, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PACEMAKER FOUND TO HAVE INTERMITTENT LOSS OF VENTRICULAR CAPTURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PACEMAKER.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308644 CAPSURE FIX PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 4068-52 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR