BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3202431 · Received July 2, 2013

    Report

    Report Number
    1723170-2013-00494
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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

    NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    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 SYSTEM WENT UNRESPONSIVE AT A BLACK SCREEN DURING A SPINE PROCEDURE WHILE ATTEMPTING TO ROTATE THE 3D MODEL. THEY REBOOTED THE SYSTEM AND THIS ISSUE OCCURRED AGAIN. MIKE REBOOTED AND WENT TO A LINUX WINDOW TO ATTEMPT TO GET THE LOGS. WHILE AT THE LINUX WINDOW, THE SCREEN WENT BLACK AGAIN AND BECAME UNRESPONSIVE TO WHERE THE NUMLOCK KEY WOULD NOT CHANGE THE STATUS OF THE NUMLOCK LIGHT. THE REP REPORTED THAT THE ISSUE OCCURS EACH TIME HE TRIES TO MANIPULATE EITHER THE 3D OR MIP VIEWS. USING THE MOVE BUTTON FROM THE LEFT PANEL, AS SOON AS HE GRABS THE IMAGE, THE SCREEN GOES BLACK. THE CASE PROCEEDED WITH JUST ORTHOGONAL VIEWS AND NO 3D VIEW. THERE WAS NO IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301147 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR