BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEATHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081229 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00814
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE UNK. MEDTRONIC REP REINSTALLED SOFTWARE AND THE ISSUE HAS NOT BEEN REPLICATED AND HAS NOT OCCURRED SINCE. NO IMPACT ON PT OUTCOME REPORTED.

    Description of Event or Problem · 1

    SURGEON REPORTED A PROBLEM WITH THE TREON SYSTEM USING THE SPINE SYNERGY SOFTWARE. THE TREON FAILED SIX TIMES YESTERDAY DURING THE SURGERY. SURGEON COMPLETED SURGERY WITH NAVIGATION. NO IMPACT ON PT OUTCOME REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK