BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2101694 · Received May 11, 2011

    Report

    Report Number
    1723170-2011-00952
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    July 12, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE AT THE TIME OF THIS RETROSPECTIVE REPORT. THE SOFTWARE INVESTIGATION WAS COMPLETED. THE ISSUE WAS ADDED TO A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE. A WORK AROUND WAS PROVIDED TO THE SITE. THE ISSUE WAS FIXED WITH THE 2.0 RELEASE OF SYNERGY SPINE AND TRAUMA SOFTWARE.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THERE WERE INVERSE CT IMAGES DURING A SPINE CASE WITH SYNERGY SPINE VERSION 1.6 SOFTWARE. THIS PROBLEM OCCURS WHEN, IN THE PLANNING PHASE THE DISPLAY SCREEN (AXIAL-CORONAL-SAGITTAL - TRAJECTORY VIEWS) IS MODIFIED VIA THE CYCLE BUTTON VIEWS. THERE WAS NO IMPACT TO PATIENT OUTCOME.

    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