BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1943921 · Received December 1, 2010

    Report

    Report Number
    1723170-2010-00118
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED AT THE SITE. THE SYSTEM FROZE, WAS REBOOTED, AND THEN WAS FOUND TO BE FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED FROM THE SITE THAT THE SYSTEM WAS FREEZING WHILE LOADING AN EXAM. SYSTEM WAS NOT RESPONSIVE TO KEYBOARD, MOUSE OF TOUCHSCREEN. THERE WAS NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE