BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2181276 · Received July 8, 2011

    Report

    Report Number
    1723170-2011-01205
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. RMA ISSUED FOR A REPLACEMENT POWER CORD KIT. ON (B)(4) 2011, THE REPLACEMENT POWER CORD KIT WAS INSTALLED AND SYS IS WORKING PROPERLY. DAMAGED POWER REEL WAS DISPOSED OF AND UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    A REGISTERED NURSE REPORTED THAT AS HE WAS MANIPULATING THE POWER CORD FROM THE REEL TO THE ISOLATION TRANSFORMER, THE STEALTHSTATION TREON GUIDANCE SYS POWERED DOWN AND HE WAS UNABLE TO POWER IT UP AGAIN. A MEDTRONIC REP INSTRUCTED THE NURSE TO PLUG THE ISOLATION TRANSFORMER DIRECTLY INTO THE WALL, AND THE SYS POWERED UP PROPERLY. THIS OCCURRED WHILE SETTING UP FOR A CASE WITHOUT A 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