BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2172130 · Received June 24, 2011

    Report

    Report Number
    1723170-2011-01152
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED FOR CAMERA AND CABLE. MEDTRONIC INVESTIGATION FINDS THAT WHEN CONNECTED TO KNOWN GOOD SYSTEM, THE PSU PERFORMED AS EXPECTED. WAS ABLE TO LOAD AN EXAM, VERIFY INSTRUMENTS, BOTH ACTIVE AND PASSIVE, AND TRACK IN NAVIGATION WITHOUT ISSUE. DID NOT EVER SEE A RED X ON ANY INSTRUMENTS, BUT A RED X APPEARS ON THE CAMERA BUTTON BEFORE THE INSTRUMENTS ARE VERIFIED. THE PSU SUBSEQUENTLY PASSED THE AAK TEST AT .12MM. PSU WAS FOUND TO BE FULLY FUNCTIONAL. THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. ISSUE COULD NOT BE REPLICATED. NO PROBLEMS FOUND.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SURGEON IS ABLE TO REGISTER INSTRUMENTS AND THEN THEY TRACK INTERMITTENTLY. THE SOFTWARE SHOWS RED X ON ALL INSTRUMENTS. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 AFTER REBOOTING THE SYSTEM. THERE WAS NO IMPACT ON THE 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 14 YR