BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1043030 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33615
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    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 77 YR Other THE DEVICE 0125/205950 WAS IMPLANTED 27-OCT-1996| THE DEVICE 1763/801218 WAS IMPLANTED 27-OCT-1996| THE DEVICE 1861/251095 WAS IMPLANTED 11-JUL-2003| THE DEVICE 4471/308890 WAS IMPLANTED 11-JUL-2003| THE DEVICE 4542/122892 WAS IMPLANTED 18-FEB-2008| THE DEVICE 4554/161260 WAS IMPLANTED 18-FEB-2008| THE DEVICE H217/715178 WAS IMPLANTED 18-FEB-2008