BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1950164 · Received December 9, 2010

    Report

    Report Number
    1723170-2010-00160
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 3, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE ATTEMPTS MADE TO OBTAIN PT INFO WITHOUT SUCCESS. THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYSTEM WAS FULLY FUNCTIONAL. SOFTWARE INVESTIGATION FOUND THAT THE SYSTEM BEHAVED AS DESIGNED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN THE SPINE APPLICATION AND AFTER FLUOROMERGE REGISTRATION, THEY WERE 6CM INACCURATE. THE SURGEON DECIDED TO DISCONTINUE USE OF NAVIGATION AND PROCEEDED WITH THE CASE USING THE C-ARM. THERE WAS NO PT IMPACT 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 NA