BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081288 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00823
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION FINDS THE POSSIBILITY OF A BUMPED FRAME OR DRAPING MATERIAL CAUGHT UNDER STERILE FRAME. UNABLE TO GET FURTHER INFO.

    Description of Event or Problem · 1

    THE SITE CALLED IN TO REPORT THAT THE SURGEON WAS INACCURATE 2 - 3 MM AFTER DRAPING AND PLACING ON A STERILE FRAME. IT WAS ALSO REPORTED THAT THE APPLICATION EXITED RANDOMLY WHILE IN THE REGISTRATION SCREEN REQUIRING THEM TO GO BACK INTO MACH CRANIAL. HOWEVER, THEY COULD NOT REPLICATE THE BEHAVIOR. THEY CHANGED THE SPHERES ON THE FRAME AND ONE OF THE SPHERES WAS CAUSING INTERMITTENT COMMUNICATION, RED/GREEN STATUS, THE ERROR WAS RANGING FROM .26 TO 1.06. WHEN THEY REMOVED THE SPHERE, THEY REPORTED THE 2 - 3 MM INACCURACY AND CONFIRMED THE INITIAL TOUCH AND GO REGISTRATION ACCURACY WAS GOOD. THEY CONFIRMED THAT THE VERTEK ARM HAD NOT MOVED OUT OF POSITION DURING DRAPING. THE USE OF THE NAVIGATION WAS DISCONTINUED WITH NO IMPACT ON THE PT OUTCOME REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR