BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2150563 · Received June 22, 2011

    Report

    Report Number
    1723170-2011-01130
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. MEDTRONIC FOLLOW-UP INVESTIGATION FINDS THE SYSTEM IS FULLY FUNCTIONAL. NO ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED AN INTERMITTENT TRACKING PROBLEM WHILE IN A SPINE CASE. SHE EXPLAINED THAT THE CAMERA WAS SEEING THE C-ARM TRACKER FINE BUT PATIENT FRAME WILL ONLY TRACK WHILE THE CAMERA IS MOVING. THE MEDTRONIC REPRESENTATIVE ASKED HER TO TWIST AND CLEAN THE SPHERES AND THEN TO REPLACE THE SPHERES. THE FRAME TRACKED PROPERLY WITHOUT FURTHER ISSUE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION TREON GUIDANCE SYSTEM. THERE WAS NO REPORTED IMPACT ON THE PATIENT OUTCOME.

    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 57 YR