BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARGE EPICARDIAL PATCH LEAD

    MDR report key: 637887 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06842
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    November 20, 2003
    Report Date
    November 29, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE EPICARDIAL DEFIBRILLATION PATCH AND EPICARDIAL RATE/SENSE LEAD SYSTEM WERE INFECTED AND DURING THE EXPLANT PROCEDURE, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE EPICARDIAL PATCH LEAD IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0041 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death