BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2081510 · Received April 19, 2011

    Report

    Report Number
    1723170-2011-00891
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION WAS COMPLETED. ISSUE DETERMINED TO BE DUE TO VIEWS LAYOUT IN TRANSLATED LANGUAGES. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT HE INSTALLED SYNERGY CRANIAL 2.1.5 WITH STEALTHMERGE AND STEALTH 3D IN A ROLLING STONE COMPUTER SYSTEM. IN THE PLAN VIEW, WHEN THE MEDTRONIC REPRESENTATIVE SELECTED THE 6 VIEWS BOX AND TRIED TO ADD THE VIEW TYPES, THE SOFTWARE FROZE AND HE HAD TO RE-START BY PRESSING CTRL + ALT + BACKSPACE. THE MEDTRONIC REP STATED THAT THE BEHAVIOR IS THE SAME SELECTING OTHER VIEWS OR IN NAVIGATE. THERE WAS NO PT PRESENT.

    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 NONE