BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 2193644 · Received July 13, 2011

    Report

    Report Number
    1723170-2011-01227
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 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

    MEDTRONIC REPRESENTATIVE PROVIDED ADDITIONAL INSTRUCTIONS TO IMPROVE PRONE REGISTRATION EXPERIENCE. THE SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED DURING A CASE THE INITIAL REGISTRATION WAS A 2.1 AND WAS VISIBLY ACCURATE WHEN CHECKING THE LEFT/RIGHT MASTOID FIDUCIALS AND THE ENYON. THE PATIENT HAD TO BE REPOSITIONED BECAUSE THE LOWER IMRI COIL WOULDN'T FIT UNDER THE PATIENT'S FACE AND RE-REGISTRATION WAS NECESSARY. THE SECOND POINT MERGE REGISTRATION WAS 2.5 AND WAS VISIBLY OFF BY A CENTIMETER WHEN CHECKING THE MASTOID FIDUCIALS. TRACER WAS ATTEMPTED BUT MORE INACCURATE BECAUSE PATIENT'S HEAD WAS TUCKED UNDER, FACIAL ANATOMY HARD TO GET TO, AND THICK DRAPING HAIR WAS A CONSTANT OBSTACLE. THEY REVERTED BACK TO POINT MERGE AND GOT DOWN TO A 2.4 REGISTRATION AND THE MASTOID FIDUCIALS AND ENYON FINALLY, ONCE AGAIN, LOOKED ACCURATE SO THE CASE PROCEEDED AS PLANNED. THE CASE WENT WELL. NO IMPACT ON PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. I7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR