BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2040339 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00655
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS INVOLVED IN THIS CONCERN. MEDTRONIC REP EVALUATED THE SYSTEM ON SITE AND COULD NOT DUPLICATE THE ISSUE. THE SYSTEM IS WORKING PROPERLY.

    Description of Event or Problem · 1

    A SITE REP REPORTED THAT THE CAMERA/PSU (POSITIONING SENSOR UNIT) IS BEEPING CONSTANTLY. IT WOULD SWITCH FROM A CONSTANT BEEP TO A BEEP-PAUSE-BEEP CONSTANTLY. A MEDTRONIC REP WALKED THROUGH TROUBLE-SHOOTING THE SOFTWARE AND CHECK THE CAMERA DIAGNOSTICS, HOWEVER, THE ISSUE PERSISTED AND THE STATUS REMAINED BLACK. THEN SYSTEM BEGAN COMMUNICATING WITH THE PSU AND THEN WENT TO RED STATUS. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1