BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK

    MDR report key: 605494 · Received November 9, 2004

    Report

    Report Number
    2124215-2004-08489
    Event Type
    Malfunction
    Date Received
    November 9, 2004
    Date of Event
    July 12, 2004
    Report Date
    July 12, 2004
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR PACING LEAD WAS EXPLANTED WHEN IT EXHIBITED LOSS OF CAPTURE AT @ 7 5V @ 2 OMS. THE LEAD WAS REPORTED TO BE CLOTTED. ,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD NIK CARDIAC PACEMAKERS, INC 4513 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other