BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2063280 · Received March 22, 2011

    Report

    Report Number
    1723170-2011-00699
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. PART RETURNED UNDER RMA. THERE IS A BURNT SPOT AT THE +12 VOLTS PIN ON THE CONNECTOR THAT ATTACHES TO THE MONITOR POWER SUPPLY; [SHORT] DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A SITE REP REPORTED THE MONITOR DISPLAYED BLACK UPON BOOT-UP AND WAS MAKING A CLICKING SOUND. A MEDTRONIC REP WALKED THE SITE THROUGH TROUBLESHOOTING AND THEY WERE ABLE TO RESTORE THE CONNECTION AFTER RE-SEATING THE CABLE, HOWEVER, THE SAME BEHAVIOR REOCCURRED WITH THE MONITOR GOING BLACK AND CLICKING. THERE WAS NO PT PRESENT.

    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