BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2072401 · Received April 8, 2011

    Report

    Report Number
    1723170-2011-00768
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    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

    NO PATIENT INFORMATION AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE TREON PSU (CAMERA) AND TOOL INTERFACE UNIT (TIU) WERE RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THERE WAS NO PROBLEM FOUND WITH THE RETURNED DEVICES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE CAMERA ON THE SITE'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STARTED CYCLING CONTINUOUSLY AND THEN WENT TO BLACK STATUS. THERE WAS NO PATIENT PRESENT.

    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 NONE