BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1253924 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40515
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4470 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention THE DEVICE 4456/473567 WAS IMPLANTED 10-SEP-2008| THE DEVICE 4469/499768 WAS IMPLANTED 10-SEP-2008| THE DEVICE S603/104759 WAS IMPLANTED 10-SEP-2008