BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTRONIC - 343081- LEXOS DR

    MDR report key: 593177 · Received April 15, 2005

    Report

    Report Number
    MW1035238
    Event Type
    Death
    Date Received
    April 15, 2005
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN WAS ON AT REMOTE DEVICE - CHARGED WITHOUT KNOWLEDGE - TECH DENIES TOUCHING DEVICE BUT NURSE WAS QUESTIONING TECHNICIAN IN FRONT OF FAMILY. RPTR BELIEVES THE TECH HIT A BUTTON INAPPROPRIATELY AND THE PACEMAKER STRIPS ARE NOT BEING GIVEN TO FAMILY EVEN THOUGH REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTRONIC - 343081- LEXOS DR AICD AND LEADS/MEDTRONIC --- BIOTRONIK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death