BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1042432 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34219
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4472 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other THE DEVICE 1290/705287 WAS IMPLANTED 24-DEC-2004| THE DEVICE 4087/227613 WAS IMPLANTED 24-DEC-2004