BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2081198 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00816
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 18, 2010
    Report Date
    March 18, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    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

    PER SOFTWARE INVESTIGATION, THE ISSUE OCCURS IF USER CREATES A/ MANY PLAN(S) IN THE NAVIGATE TASK AND COMES ACROSS A FREEZE/ CRASH SCENARIO WHERE USER HAS TO EITHER DO A HARD SHUT DOWN OR PRESS CTRL+ALT+BACKSPACE. WHEN USER RE-ENTERS S/W THEN THE PLANS ARE NOT AVAILABLE ANYMORE. THIS IS BECAUSE, THE PLANS ARE CREATED IN NAVIGATE TASK AND SINCE A PROPER EXIT PATTERN IS NOT FOLLOWED, THE PLANS ARE NOT TRIGGERED TO GET SAVED.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THAT WHILE IN NAVIGATE, SHE COULD NOT CLOSE THE TOOL BAR ON THE RIGHT HAND SIDE OF THE SCREEN. SEVERAL MINUTES LATER, THE SOFTWARE FROZE IN NAVIGATE MODE. THE REP PERFORMED A HARD SHUTDOWN. WHEN SHE CAME BACK IN TO THE APPLICATION, THE REGISTRATION WAS PRESENT BUT THE SURGICAL PLANS WERE MISSING. THE SURGEON HAD THREE SURGICAL PLANS CREATED PRIOR TO THE FREEZE. NO IMPACT ON PT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK