BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2020249 · Received March 10, 2011

    Report

    Report Number
    1723170-2011-00628
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    August 24, 2009
    Report Date
    August 24, 2009
    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

    NO PT INFO WAS AVAILABLE AT THE TIME OF THIS RETROSPECTIVE REPORT. (B)(4). THERE WAS NO ALLEGED DEFICIENCY OF A MEDTRONIC PRODUCT. THE ISSUE WAS RELATED TO THE USER NOT FOLLOWING SCAN PROTOCOL (USE ERROR) WHICH HAD THE POTENTIAL TO HARM THE PT. THE SYSTEM BEHAVED AS DESIGNED AND THE USER WAS INFORMED OF THE RISK.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THEY HAD LOADED A SCAN WITH 2.0MM SLICES, 2.1MM SLICE THICKNESS USING A STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THEY RECEIVED A NON-CONTIGUOUS SLICE ERROR. THE MEDTRONIC REPRESENTATIVE TOLD THE DOCTOR THEY COULD EXPERIENCE INACCURACIES SINCE THEY DID NOT FOLLOW SCAN PROTOCOL. THE DOCTOR SAID HE STILL WANTED TO USE THE SCAN AND WAS GOING TO PROCEED WITH THE CASE. THERE WAS NO IMPACT 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