BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050108 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00567
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT PRESENT. UPGRADING THE SOFTWARE ON THE O-ARM RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED THAT THE IMAGES WERE FROZEN ON THE TREON NAVIGATION SYSTEM SCREEN AFTER THE 3D IMAGE WAS TRANSFERRED FROM THE O-ARM SYSTEM. HE COULD NO LONGER USE ANYTHING (MOUSE, TOUCHSCREEN) AND NEEDED TO DO A HARD REBOOT TO RESOLVE THE ISSUE. THIS ISSUE OCCURRED AT THE END OF SPINE SURGERY WITH NO PT HARM ALLEGED.

    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 O-ARM 1000 IMAGING SYSTEM