BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081217 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00847
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS INVOLVED IN THIS CONCERN. SOFTWARE INVESTIGATION STILL IN PROGRESS.

    Description of Event or Problem · 1

    SITE REPORTED THEIR TREON PLUS SYSTEM SUDDENLY LOGS OUT TO THE MAIN MENU DURING NAVIGATION. ALSO, WHEN THEY SWITCH ON THE TREON NAVIGATION SYSTEM, IT FREEZES IN THE INITIALIZING SCREEN AND IS NOT ABLE BOOT TO THE MAIN MENU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1