BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL NEUROGENERATOR

    MDR report key: 143404 · Received January 12, 1998

    Report

    Report Number
    143404
    Event Type
    Other
    Date Received
    January 12, 1998
    Date of Event
    December 23, 1997
    Report Date
    January 5, 1998
    Manufacturer
    ELEKTA INTRUMENTS INC
    Product Code
    GXD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SET UP FOR PROCEDURE, EQUIPMENT TURNED ON FOR PRECHECK. SYSTEM ERROR NOTED M.D. REFERRED TO OPERATIONAL MANUAL. ERROR NOTED TO BE RELATED TO ROOM TEMPERATURE. UNIT CUT OFF, AND RESTARTED. NO SYSTEM ERROR NOTED. PROCEDURE STARTED, TEMPERATURE ELEVATED ABOVE SET TEMPERATURE. EQUIPMENT SHUT OFF. PT NOTED TO BE DISORIENTED. PT RETURNED TO UNIT, CT SCAN DONE, EDEMA NOTED AT SURGICAL SITE. CT REPEATED, EDEMA DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL NEUROGENERATOR COAGULATOR GXD ELEKTA INTRUMENTS INC LNG30-1 789

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other