BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7¿ PLANNING STATION

    MDR report key: 3011297 · Received March 19, 2013

    Report

    Report Number
    1723170-2013-00190
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REPRESENTATIVE FOLLOWING-UP FINDS THE SURGEONS NOTED THE CONCERN DURING THE PLANNING ON THE TRAJECTORY AND THE LOOK-AHEAD VIEW, LEADS WERE PLACED CORRECTLY. SOFTWARE INVESTIGATION WAS COMPLETED: ROOT CAUSE DETERMINED TO BE VISUALIZATION AND LOOK-AHEAD. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ALLEGATION OF AN ISSUE WITH LOOK-AHEAD IN FRAMELINK 5.4 RS WHILE IN A CRANIAL PROCEDURE. THE SURGEON WAS USING A STANDARD INSTALLATION OF FRAMELINK 5.4 UTILIZING THE LOOK AHEAD FUNCTION IN 512 RESOLUTION IMAGES. THE STEPS OF THE LOOK-AHEAD WERE TWICE AS DEEP AS THEY WERE INDICATED. IT APPEARED THE USER CHECKED IN SMALL STEPS OF 2MM THE SAFETY BUT IN REALITY, CHECKED IN 4MM STEPS. WHEN CHANGING A PARAMETER IN .XDEFAULTS (''FULL SLICE STACK RESOLUTION'' = FALSE) THE RESOLUTION OF THE IMAGE IS DOWN SAMPLED FROM 512 RESOLUTION TO 256 DURING THE IMPORT OF DATASET. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE S7 PLANNING STATION. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113657 STEALTHSTATION® S7¿ PLANNING STATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7 PLANNING STATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR