BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACEMAKER LEAD & ADAPTER

    MDR report key: 908347 · Received September 2, 2007

    Report

    Report Number
    MW5003630
    Event Type
    Death
    Date Received
    September 2, 2007
    Date of Event
    June 3, 2005
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC LEAD MODEL #5076 WAS IMPLANTED IN 2004. HOWEVER, MEDTRONIC DATA BASES DOES NOT HAVE THIS LEAD MODEL AS BEING IMPLANTED. SO WHEN POST IMPLANTATION INTERROGATION WAS PERFORM BY MEDTRONIC THE CORRECT DATA MAY NOT HAVE BEEN RECORDED. IN 2005, LEAD WAS STILL IMPLANTED AT TIME OF DEATH. MEDTRONIC INC COULD NOT HAVE COLLECTED CORRECT FUNCTION DATA POST IMPLANTATION BECAUSE THIS MODEL IS NOT WHAT IS DOCUMENT AS BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACEMAKER LEAD & ADAPTER NONE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death