BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 1042856 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33775
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 21, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE 4096/119142 WAS IMPLANTED| THE DEVICE 0185/156331 WAS IMPLANTED 22-JAN-2007| THE DEVICE T175/119475 WAS IMPLANTED 22-JAN-2007| THE DEVICE H195/351632 WAS IMPLANTED| THE DEVICE 4525/162911 WAS IMPLANTED| THE DEVICE 4518/329923 WAS IMPLANTED