BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1042520 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34111
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 FINELINE II IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4459 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 1298/001824 WAS IMPLANTED| THE DEVICE 1298/1824 WAS IMPLANTED| THE DEVICE 1298/182441 WAS IMPLANTED| THE DEVICE 4471/N.A. WAS IMPLANTED