BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE EPICARDIAL PATCH LEAD

    MDR report key: 1041628 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31906
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    September 29, 2004
    Report Date
    January 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE EPICARDIAL PATCH LEAD IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0068 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other THE DEVICE 4047/087253 WAS IMPLANTED 01-JUL-2004| THE DEVICE T180/212826 WAS IMPLANTED 29-JAN-2008| THE DEVICE 1853/408968 WAS IMPLANTED 01-JUL-2004| THE DEVICE 0185/187375 WAS IMPLANTED 29-JAN-2008| THE DEVICE 4047/085260 WAS IMPLANTED 01-JUL-2004