BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1042817 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33820
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other THE DEVICE 1290/765947 WAS IMPLANTED 13-NOV-2006| THE DEVICE 4457/520652 WAS IMPLANTED 13-NOV-2006