BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD CV EZTRK 2 BP IS1 4542 80CM US

    MDR report key: 1043363 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33276
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LD CV EZTRK 2 BP IS1 4542 80CM US IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4542 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other THE DEVICE 4554/159677 WAS IMPLANTED 06-FEB-2008| THE DEVICE 4271/211151 WAS IMPLANTED 21-FEB-1997| THE DEVICE 0148/126953 WAS IMPLANTED 28-OCT-2002| THE DEVICE 4542/123152 WAS IMPLANTED 06-FEB-2008| THE DEVICE H210/201076 WAS IMPLANTED 17-JAN-2006| THE DEVICE UNKN/ WAS IMPLANTED| THE DEVICE 4260/050415 WAS IMPLANTED 28-AUG-1990