BEUDAMED
    FDA Adverse Event Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1942486 · Received November 22, 2010

    Report

    Report Number
    1723170-2010-00099
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    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

    PT INFO UNAVAILABLE AT TIME OF THIS REPORT. INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED SURGEON ALLEGED 2MM INACCURACY IN A CRANIAL SURGERY. THE CASE WENT WELL AND THERE WAS NO PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK