BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2013549 · Received February 3, 2011

    Report

    Report Number
    1723170-2011-00077
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE REPORTED EVENT, THE ACCOUNT DID NOT HAVE THE SYSTEM PLUGGED INTO A WORKING OUTLET. THE ELECTRICAL FACILITIES AT THE SITE CONTRIBUTED TO THE EVENT. THE ISSUE WAS RESOLVED BY SWITCHING TO A FUNCTIONAL OUTLET.

    Description of Event or Problem · 1

    A SITE REP REPORTED, THE STEALTHSTATION NAVIGATION SYSTEM POWERED OFF DURING A CASE. THE OPERATING ROOM STAFF ALLEGEDLY LOST ALL OF THE INFO ON THE SYSTEM WHEN THIS ISSUE OCCURRED. THE SURGEON CONTINUED THE SURGERY WITHOUT THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON PT OUTCOME. LATER DISCOVERY SHOWED THE SITE DID NOT HAVE THE SYSTEM PLUGGED INTO A WORKING OUTLET.

    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 83 YR