BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH STATION SYSTEM

    MDR report key: 439603 · Received January 23, 2003

    Report

    Report Number
    1723170-2003-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2003
    Date of Event
    December 1, 2002
    Report Date
    January 23, 2003
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STEALTHSTATION SOFTWARE TARGET CENTRIC GUIDANCE VIEW ASSISTS THE SURGEON IN DIRECTING AN IMAGE GUIDE INSTRUMENT ALONG A SURGICAL PLAN TOWARD A SPECIFIC TARGET. THIS VIEW IS MOST COMMONLY USED FOR IMAGE GUIDED NEEDLE BIOSY PROCEDURES. THE TARGET CENTRIC GUIDANCE VIEW MONITORS THE POSITION OF THE INSTRUMENT'S TIP ALONG THE SURGICAL PLAN AS THE INSTRUMENT IS ADVANCED. THE POSITION ALONG THE PLAN IS REPRESENTED BY A BLUE ARROW THAT MOVES DOWN THE RIGHT EDGE OF THE GUIDANCE VIEW AS THE INSTRUMENT IS ADVANCED. WHEN THE BLUE ARROW REACHES THE BORDER OF THE RED AREA, THE TOP OF THE INSTRUMENT HAS REACHED ITS PREDEFINED TARGET. HOWEVER, IN THE STEALTHSTATION SOFTWARE TARGET CENTRIC GUIDANCE VIEW VERSIONS 4.1.2 AND 4.1.3 THE INDICATOR ARROW REVERSES DIRECTION, INDICATING WITHDRAWAL AS THE INSTRUMENT ADVANCES. THE DISTANCE THE INDICATOR ARROW WITHDRAWS IS THE EQUIVALENT TO THE DISTANCE BY WHICH THE TARGET HAS BEEN OVERSHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTH STATION SYSTEM STEREOTACTIC DEVICE HAW MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 960-095 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other