BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2033608 · Received February 11, 2011

    Report

    Report Number
    1723170-2011-00113
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT AVAILABLE AT TIME OF THIS REPORT. THE DEVICE PERFORMED AS INTENDED. THIS ISSUE IS BEING REPORTED BECAUSE THE USAGE OF THE DEVICE IN THIS MANNER COULD RESULT IN INACCURATE NAVIGATION WHICH CANNOT BE MITIGATED.

    Description of Event or Problem · 1

    A SITE OPERATING ROOM REP REPORTED THAT THEY ARE UNABLE TO CALIBRATE THE SURETRAK II. THE DOCTOR WAS USING A FLEXIBLE INSTRUMENT TO PLACE A CATHETER. THE MEDTRONIC TECHNICAL SVCS REP WARNED THE DOCTOR THAT THE INSTRUMENT IS TIP-TRACKED AND IT IS NOT RECOMMENDED TO USE FLEXIBLE INSTRUMENTS. THE DOCTOR REPLIED THAT HE WAS AWARE OF THAT BUT WANTED TO USE IT, ANYWAY. THE SURGEON COMPLETED THE CASE WITH THE USE OF THE STEALTHSTATION. THERE WAS NO REPORTED HARM TO THE PT.

    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 UNK