BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2519847 · Received April 4, 2012

    Report

    Report Number
    1723170-2012-00166
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    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

    SOFTWARE EVALUATION WAS COMPLETED. FINDINGS ARE THAT THE FRAME TO PT RELATIONSHIP WAS CHANGED MAKING THE REGISTRATION INVALID. ACCURACY CHECKPOINTS NEED TO BE IDENTIFIABLE IN A STERILE FIELD AND THE POINTS WERE NOT STORED WHERE THEY COULD BE PROPERLY RE-TOUCHED IN A STERILE FIELD. SOFTWARE IS FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A TRANSPHENOIDAL CASE THE FRAME WAS BUMPED AND MOVED DURING AN INTRA-OPERATIVE IMRI SCAN. DURING THE INITIAL POINT-MERGE REGISTRATION THE SITE HAD PREVIOUSLY STORED FOUR ACCURACY CHECK-POINTS ON THE PT'S FOREHEAD. THESE POINTS WERE MARKED IN A TRAPEZOIDAL PATTERN AT THE FOUR CORNERS OF THE PTS FOREHEAD. HOWEVER, DURING THE SURGERY, THE SITE RE-DRAPED OVER THE FOREHEAD AND THE INK ON THE PT'S HEAD BLED SLIGHTLY MAKING THE POINTS FUZZY. THE SITE ATTEMPTED TO VERIFY THE CHECKPOINTS FOUR TIMES WITH THEIR PROBE BEFORE SUCCESSFULLY MATCHING THEM BETWEEN THE PT AND THE SOFTWARE. THE SURGEON THEN REPORTED THAT HE FELT INACCURATE WHEN TOUCHING THE BONY PORTION OF THE PT'S NOSE; ALLEGING A 3-5 MM INACCURACY AS HE NAVIGATED DEEPER TO THE BONY ANATOMY OF THE NOSE. THE SURGERY HAD PROGRESSED AND NAVIGATION WAS NOT NEEDED AFTER THE POINT WHERE THE SURGEON FELT INACCURATE. THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON PT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION IOR SYSTEM STEREOTAXIC INSTRUMETN (HAW) HAW MEDTRONIC NAVIGATION, INC. IO4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR