BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3903010 · Received June 30, 2014

    Report

    Report Number
    1723170-2014-00697
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE.NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A SITE BIOMED REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, THE OPERATING ROOM STAFF STATED THAT THEIR NAVIGATION SYSTEM SHUT-DOWN. NO FURTHER DETAILS REGARDING THIS ISSUE WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380698 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1