BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1041562 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31979
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    August 30, 2007
    Report Date
    February 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4474 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 0128/101337 WAS IMPLANTED 01-JAN-2001| THE DEVICE 1860/143637 WAS IMPLANTED 02-DEC-2005