BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIDELIS LEAD

    MDR report key: 3003695 · Received March 12, 2013

    Report

    Report Number
    3003695
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIDELIS LEAD REMOVED AND REPLACED. BI-V ICD WAS NOT RECORDING ANY PACING. MEDTRONIC RECOMMENDED EXCHANGING IT OUT. ATRIAL LEAD REMOVED BECAUSE OF HIGH THRESHOLD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEAD REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103317 FIDELIS LEAD DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD NIK MEDTRONIC 6949 *
    103318 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD LWS MEDTRONIC D314TRG *
    103319 CAPSUREFIX NOVUS PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 4076 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR