BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2040341 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00660
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A SITE REP REPORTED THAT DURING A CASE THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM SHUT DOWN WHILE IN USE AND WOULD NOT TURN ON. THEY TRIED SEVERAL OUTLETS AND HEARD BEEPING FROM THE UPS. A MEDTRONIC REP WALKED THROUGH TROUBLESHOOTING WITH THE SITE REP, REQUESTING THEY BYPASS THE POWER CHAIN AND REMOVE THE BACK PANEL. THE SITE REP SAID THEY BROUGHT A SECOND SYSTEM INTO THE ROOM AND WOULD USE THAT SYSTEM. WHILE SETTING UP THE SECOND SYSTEM, THEY BYPASSED THE POWER CHAIN AND THE SYSTEM WOULD NOT BOOT UP. HAD HER CHECK THE COMPUTER POWER CORD CONNECTION AND IT WAS SECURE. THE SURGEON COMPLETED THE SURGERY. THERE WAS NO IMPACT ON THE PT 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 67 YR