BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1254024 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40883
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 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 68 YR Other THE DEVICE 0158/158750 WAS IMPLANTED 08-DEC-2005| THE DEVICE 4470/582489 WAS IMPLANTED 24-SEP-2008| THE DEVICE 4513/409777 WAS IMPLANTED 08-DEC-2005| THE DEVICE 4518/317260 WAS IMPLANTED 08-DEC-2005| THE DEVICE 6482 000577 WAS USED DURING THE EVENT.| THE DEVICE 6482 003432 WAS USED DURING THE EVENT.| THE DEVICE 6482 012446 WAS USED DURING THE EVENT.| THE DEVICE H219/200473 WAS IMPLANTED 08-DEC-2005| THE DEVICE N118/560340 WAS IMPLANTED 24-SEP-2008