BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA ENTRA

    MDR report key: 682764 · Received March 3, 2006

    Report

    Report Number
    2124215-2006-99334
    Event Type
    Death
    Date Received
    March 3, 2006
    Date of Event
    February 7, 2006
    Report Date
    March 3, 2006
    Manufacturer
    CLONMEL
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFO THAT THE PT WAS THIS PACEMAKER, WHICH WAS INCLUDED IN THE POPULATION OF A RECENT FIELD ADVISORY REGARDING FAILURE MODE 1, DIED OF AN UNK CAUSE. HOWEVER, THE PT'S FAMILY IS NOW PURSUING LITIGATION RELATED TO THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ENTRA IMPLANTABLE PULSE GENERATOR DXY CLONMEL 1294 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death