BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1960424 · Received December 16, 2010

    Report

    Report Number
    1723170-2010-00183
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    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

    THE SYSTEM WAS EVALUATED AT THE SITE. THE SYSTEM WAS FULLY FUNCTIONAL AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES. THE SOFTWARE INVESTIGATION FOUND THAT THE SYSTEM BEHAVED AS DESIGNED. INFORMATION WAS PROVIDED TO THE CUSTOMER REGARDING PROPER SYSTEM SETUP.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON ALLEGED AN INACCURACY WHILE NAVIGATING WITH THE SYSTEM IN A CRANIAL SURGERY. SURGEON CONTINUED USE OF THE SYSTEM AND COMPLETED THE SURGERY. THERE WAS NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK