BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2072394 · Received April 8, 2011

    Report

    Report Number
    1723170-2011-00766
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A SITE REP REPORTED THAT THEIR STEALTHSTATION TREON GUIDANCE SYS FROZE AFTER TAKING A SNAPSHOT DURING A CASE. NAVIGATION WAS FUNCTIONING NORMALLY AND THEY WERE ABLE TO STOP NAVIGATION WITH THE FOOT PEDAL TO TAKE THE SNAPSHOT, BUT WHEN TRYING TO RETURN TO NAVIGATION, THE SYS WOULD NOT RESPOND USING THE FOOT PEDAL OR THE FOOT PEDAL ICON ON THE MONITOR. AFTER A MINUTE, THE SYS UNFROZE AND RETURNED TO REGULAR OPERATION. THIS OCCURRED TWO TIMES DURING THE CASE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.

    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 53 YR