BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE EPICARDIAL PATCH LEAD

    MDR report key: 1002417 · Received February 7, 2008

    Report

    Report Number
    2124215-2008-31879
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    January 6, 2006
    Report Date
    November 19, 2007
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    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 LARGE EPICARDIAL PATCH LEAD IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 0068 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other THE DEVICE 0068/201328 WAS IMPLANTED 03-JUN-2005| THE DEVICE 4047/099900 WAS IMPLANTED 03-JUN-2005| THE DEVICE H177/504627 WAS IMPLANTED 03-JUN-2005| THE DEVICE 4047/100122 WAS IMPLANTED 03-JUN-2005| THE DEVICE 4047/100123 WAS IMPLANTED 03-JUN-2005