BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1042341 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34296
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4473 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other THE DEVICE 1291/118735 WAS IMPLANTED 14-MAR-2006| THE DEVICE 4474/416912 WAS IMPLANTED 14-MAR-2006