BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3193600 · Received June 27, 2013

    Report

    Report Number
    1723170-2013-00483
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT PRESENT. THE INVESTIGATION HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SOFTWARE EXITED WHILE THEY WERE CREATING PLAN PRIOR TO THE CASE. HE SAID THEY LOADED THE PATIENT EXAM, WHICH HAD 4 SERIES, AND THEN BEGAN TO CREATE PLAN. NO OTHER EXAMS WERE LOADED OR PREVIEWED AND THERE WERE NO MODELS BUILT PRIOR TO THE APPLICATION EXITING. AFTER RESTARTING THE APPLICATION, THEY WERE ABLE TO CREATE THE PLAN; AND THE SOFTWARE FUNCTIONED AS EXPECTED. THE REP SAID THERE ARE OVER 300 PATIENT EXAMS LOADED ON THE SYSTEM. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292608 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1