BEUDAMED
    FDA Adverse Event Other Summary report: N

    TREON STEALTHSTATION

    MDR report key: 1335866 · Received March 5, 2009

    Report

    Report Number
    1723170-2009-00003
    Event Type
    Other
    Date Received
    March 5, 2009
    Date of Event
    January 16, 2009
    Report Date
    February 6, 2009
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION ON SITE. SYSTEM WAS EVALUATED BY CORPORATE REPRESENTATIVE AND DETERMINED THAT RECENT UPGRADE OF SYSTEM RESULTED IN MISSING SOFTWARE MODULE NEEDED TO SUPPORT THE INSTRUMENT THAT DR. WAS ATTEMPTING TO NAVIGATE. DR. MISINTERPRETED INABILITY TO TRACK INSTRUMENT AND ASSUMED ISSUE WAS HARDWARE RELATED RATHER THAT SOFTWARE. DR. CHOSE TO PERFORM CASE WITHOUT NAVIGATION. INVESTIGATION DISCOVERED MISSING TOOL FILE AND INSTALLATION OF TOOL FILE RESOLVED ISSUE. RESULTS - INVESTIGATION SHOWED MISSING TOOL SET FROM SOFTWARE.

    Description of Event or Problem · 1

    PATIENT TO OR FOR LEFT TEMPORAL FRAMELESS STEREOTACTIC-GUIDED BIOPSY OF BRAIN TUMOR USING STEALTH NAVIGATIONAL IMAGE GUIDANCE SYSTEM FOR COMPUTERIZED STEREOTACTIC PLANNING. UNABLE TO OBTAIN GOOD TRAJECTORY VIEWS DUE TO TECHNICAL DIFFICULTIES WITH LED. PROCEDURE CONVERTED TO NON-NAVIGATED BIOPSY. BUR HOLE PLACED AND BIOPSY SUCCESSFUL. DR. REPORTED NO ADVERSE OUTCOME FROM BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREON STEALTHSTATION STEREOTACTIC SURGICAL NAVIGATION HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR