BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3192946 · Received June 27, 2013

    Report

    Report Number
    1723170-2013-00482
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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 AN UNEXPECTED SOFTWARE EXIT THAT OCCURRED OUTSIDE OF A PROCEDURE. THE SYSTEM HAD BEEN LEFT ON AT THE NAVIGATE SCREEN ALL WEEKEND. THE REP CLICKED BACK IN THE SOFTWARE TO LOOK AT OTHER EXAMS ON THE SYSTEM. WHILE ON THE MERGE SCREEN LOOKING AT PREVIOUS EXAMS, THE SOFTWARE EXITED UNEXPECTEDLY. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294434 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1