BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050152 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00547
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT DID NOT MEET SPECIFICATIONS. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. THE CABLE HAS BEEN PINCHED AND THE CABLE JACKET IS CUT EXPOSING INTERNAL WIRES. A REPLACEMENT PART WAS SENT TO THE SITE TO RESOLVE THE ISSUE. THE SYSTEM WAS EVALUATED AT THE SITE. THE SOFTWARE WAS REINSTALLED AND THE NETWORK SETTINGS WERE ADJUSTED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    SITE REP CALLED IN TO REPORT THAT DURING A CASE SYSTEM DISPLAYED A SEARCHING FOR INPUT MESSAGE THEY REBOOTED AND IT FROZE. THEY WHEELED IN ANOTHER CART AND WERE ABLE TO FINISH THE CASE. HE WOULD LIKE THE LOCAL MEDTRONIC REP TO VISIT THE SITE. 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