BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3120084 · Received May 9, 2013

    Report

    Report Number
    3120084
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A RIGHT ATRIAL LEAD AND PACEMAKER ORIGINALLY IMPLANTED IN FALL OF 2012. IN THE SPRING OF 2013, THE PATIENT WAS BROUGHT IN BECAUSE THERE WAS AN ISSUE WITH THE DEVICE. THE MD FELT THE LEAD WAS THE PROBLEM, SO HE REPOSITIONED THE LEAD, HE DID NOT REMOVE IT. THE DAY AFTER THAT, THE DEVICE WAS STILL MALFUNCTIONING. MD FELT LEAD NOT REALLY NEEDED ANYMORE AND SO IT WAS REMOVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?AS ABOVE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204702 CAPSUREFIX NOVUS PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 407645 *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R PACEMAKER