BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081264 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00808
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    January 8, 2010
    Report Date
    January 8, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REP TESTED SYSTEM. HAD TO RESET CAMERA AS SYSTEM WAS NOT SEEING FRAME. ONCE RESET, THE PROBLEM COULD NOT BE REPLICATED. NO IMPACT ON PATIENT OUTCOME REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SITE WAS EXPERIENCING RED CROSSHAIRS IN THE NAVIGATE SCREEN OF THE CRANIAL APPLICATION ON THE TREON SYSTEM, ALTHOUGH THE PROBE AND FRAME WERE GREEN STATUS. THE FRAME SEEMED TO BE POSITIONED INCORRECTLY DURING THE REGISTRATION STEP AND THEN CORRECTED AFTER DRAPING, BUT THE DR WAS INACCURATE WHEN NAVIGATING. DR OPTED TO ABORT THE CASE. NO IMPACT ON PATIENT 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 60 YR