BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6509013 · Received April 20, 2017

    Report

    Report Number
    1723170-2017-01740
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 20, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS FOUND THAT COMMUNICATION BETWEEN THE NAVIGATION SYSTEM AND THE CAMERA WAS FAILING. THE SYSTEM CONTROL UNIT (SCU), CAMERA AND CABLE WAS REPLACED. THE NAVIGATION SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE SCU WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION WAS UNABLE TO DUPLICATE REPORTED PROBLEM. THE RETURNED SCU HAS HAD THE RUBBER FEET REMOVED. OTHERWISE, WHEN CONNECTED TO A KNOWN GOOD SYSTEM THE SCU WAS FOUND TO BE FULLY FUNCTIONAL. THE SCU RAN OVERNIGHT AND DID NOT HAVE A CYCLING EVENT. A CHECK OF THE EVENT LOG DID NOT REVEAL ANY ADVERSE EVENTS. ALL TOOL PORTS ARE FUNCTIONAL. NO PROBLEM FOUND. THE POSITIONING SENSOR UNIT (PSU) AND THE SCU TO PSU CABLE HAVE NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE NAVIGATION SYSTEM'S CAMERA HAD TRACKING LOSS. THE CAMERA SWITCHES OFF MOMENTARILY. IT IS NOT FREQUENT AS WITH MISSING FIRMWARE AND THEY SUSPECT THAT THE SYSTEM CONTROL UNIT (SCU) IS FAULTY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290198 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1