BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2062468 · Received March 18, 2011

    Report

    Report Number
    1723170-2011-00679
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFORMATION AS NO PT WAS INVOLVED IN THIS CONCERN. THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THEY HAD A PROBLEM WITH THE STEALTHSTATION TREON SYSTEM DURING THE INTERVENTION. THERE WAS BAD COMMUNICATION, AND IMAGES WERE NOT ALWAYS SEEN ON THE SCREEN. THERE WAS NO PT 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