BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1254200 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-41042
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 27, 2008
    Report Date
    September 27, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 68 YR Required Intervention THE DEVICE 0185/185131 WAS IMPLANTED 14-MAR-2008| THE DEVICE 4518/329501 WAS IMPLANTED 14-MAR-2008| THE DEVICE 6482 032586 WAS USED DURING THE EVENT.| THE DEVICE H219/207475 WAS IMPLANTED 14-MAR-2008