BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON PLUS

    MDR report key: 924810 · Received October 4, 2007

    Report

    Report Number
    1723170-2007-00007
    Event Type
    Other
    Date Received
    October 4, 2007
    Date of Event
    July 30, 2007
    Report Date
    October 1, 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

    Description of Event or Problem · 1

    DR. ATTEMPTED TO PERFORM A NAVIGATED CRANIAL BIOPSY USING A MEDTRONIC NAVIGATION STEALTH STATION AND SOFTWARE 9730896 CRANIAL APPLICATION. THE MEDTRONIC FIELD REPRESENTATIVE AT THE CASE RECOUNTED THAT THE DR. INSISTED HE WAS AT THE TARGET ACCORDING TO THE NAVIGATION SCREEN AND, EVEN THOUGH THE REPRESENTATIVE SUGGESTED TO HIM THAT THE DR. WAS NOT YET TO THE TARGET DEPTH, THE DR. INSISTED HE WAS AND TOOK THE SAMPLE. THE SAMPLE TAKEN WAS IDENTIFIED AS NON TUMOROUS BRAIN TISSUE. EVIDENCE SUGGESTS THAT THE DR. WAS MISINTERPRETING THE NAVIGATION SCREEN AND THOUGHT THAT HE WAS ON HIS TARGET WHILE HE WAS ACTUALLY 3 "HASH MARKS" SHORT OF THE TARGET POINT. NO ALLEGATION OF ADVERSE PATIENT OUTCOME FROM THE PROCEDURE WAS COMMUNICATED TO MEDTRONIC NAVIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other