BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050138 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00607
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHIC UNKNOWN. PER RMA, NUMEROUS PARTS WERE SENT TO SITE TO RESOLVE ISSUE. ON RETURN OF PARTS WERE SENT TO SITE TO RESOLVE ISSUE. ON RETURN OF PARTS THE POWER SUPPLY SEEMED TO PROVIDE AN UNSTEADY 9 TO 10 VOLTS AND SPARKED DURING TESTING. POWER SUPPLY ALSO HAS BURNED PINS AT CONNECTOR. THE TREON MONITOR POWER PIGTAIL CONNECTOR IS SEVERELY BURNED AROUND RED WIRES ON FEMALE CONNECTORS. ALL OTHER PARTS WERE RETURNED UNUSED.

    Description of Event or Problem · 1

    SITE REPORTED THEIR MONITOR WENT BLACK ON THE TREON SYSTEM AFTER NATIONAL DISPLAY SYSTEM CAME UP. THE SURGEON DECIDED TO DISCONTINUE THE USE OF THE SYSTEM AND THE PROCEDURE WAS SUCCESSFUL WITHOUT IMPACT ON THE PATIENT 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