BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON PLUS

    MDR report key: 926104 · Received October 12, 2007

    Report

    Report Number
    1723170-2007-00005
    Event Type
    Other
    Date Received
    October 12, 2007
    Date of Event
    January 11, 2007
    Report Date
    September 25, 2007
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MNAV FIELD STAFF SPOKE WITH SURGEON'S OFFICE REGARDING PT OUTCOME - PT HAS FULLY RECOVERED AND ANY EQUIPMENT MALFUNCTION THAT OCCURRED WAS DETERMINED TO BE A RESULT OF SUBMERGING THEIR ACTIVE TRACKERS IN WATER AND THE LEDS BEING PLACED BACKWARD. THEY ARE NOW FOLLOWING THE NECESSARY CLEANING AND STERILIZATION PROTOCOL AND HAVE HAD NO FURTHER INTERMITTENT TRACKING ISSUES. PT INFO HAS BEEN REQUESTED FROM HOSPITAL - NO INFORMATION HAS BEEN MADE AVAILABLE YET.

    Description of Event or Problem · 1

    MNAV CASS CALLED ABOUT CRANIOTOMY CASE IN 2007. CASS CALLED BECAUSE A CHIEF RESIDENT AT THE HOSPITAL HAD MENTIONED A POTENTIAL ADVERSE OUTCOME FOR THIS PARTICULAR PT. CASS REPORTED THAT THIS PT HAD TWO TUMORS, ONE THAT WAS SUPERFICIAL AND THE SECOND THAT WAS DEEP SEATED WITHIN THE ANATOMY. IN ADDITION, CASS REPORTED THAT SURGEON HAD DECIDED TO USE BONE FIDUCIALS FOR INCREASED ACCURACY, RESULTING IN A PREDICTED ACCURACY OF LESS THAN 1MM (APPROX .6-.7MM). CASS VERIFIED THAT ALL OF THE PT ANATOMY WAS COMPLETELY SURROUNDED BY THE GREEN SPHERE OF ACCURACY BEFORE THE SURGEON WAS SATISFIED WITH THE REGISTRATION. ALLEGEDLY, SURGEON HAD INITIALLY DECIDED TO USE A NAVIGATED TRAJECTORY GUIDE FOR THE BIOPSY BUT ENDED UP PERFORMING AN OPEN CRANIOTOMY USING A PASSIVE PLANAR BLUNT AS THE NAVIGATIONAL TOOL, DUE TO INTERMITTENT TRACKING ISSUES AND TROUBLES FIXATING THE ANGLED TRAJECTORY GUIDE BASE TO THE ANATOMY. CASS REPORTED THAT THE SURGEON EXCUSED HER FROM THE OR BECAUSE HE FELT COMFORTABLE OPERATING THE NAVIGATION HIMSELF. PT SUFFERED HEMI PARALYSIS AFTER THE CASE, HOWEVER, NO ALLEGATION WAS MADE BY THE SURGEON OR HOSPITAL ABOUT THE NAVIGATION SYSTEM NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON PLUS STEREOTACTIC SURGICAL SYSTEM HAW MEDTRONIC NAVIGATION, INC. 9680111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other