BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2201183 · Received July 29, 2011

    Report

    Report Number
    1723170-2011-01259
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, RN, REPORTED THAT THE SURGEON WAS UNABLE TO VERIFY THE RIGHT TACTILE AWL WHILE IN A SPINE PROCEDURE. THE SURGEON WAS ABLE TO REGISTER THE REGISTRATION PROBE AND COMPLETE A SUCCESSFUL REGISTRATION. NEXT SHOWED THE RIGHT TACTILE AWL TO THE CAMERA AND THE SOFTWARE DID NOT CHANGE TO THE TACTILE AWL SO THEY MANUALLY SELECTED IT, HOWEVER, IT REMAINED AT RED STATUS. WHILE TROUBLESHOOTING WITH MEDTRONIC REPRESENTATIVE, THE SURGEON DECIDED TO CONTINUE THE SURGERY WITHOUT THE STEALTHSTATION TREON GUIDANCE SYSTEM AND DISCONTINUE TROUBLESHOOTING EFFORTS. THE SURGERY WAS COMPLETED WITH NO IMPACT ON THE PT 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 73 YR