BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1994319 · Received January 14, 2011

    Report

    Report Number
    1723170-2011-00045
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT NOT AVAILABLE FROM SITE. SYSTEM PERFORMED AS DESIGNED; PER REPORT, USER ERROR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THAT THE SITE ALLEGED NAVIGATION INACCURACY OF 2CM AFTER HAVING MOVED THE PT'S HEAD, CAUSING THE FRAME TO MOVE ALSO. IN RESPONSE, THEY RE-REGISTERED AND CONTINUED AS PLANNED WITH NO NEGATIVE IMPACT TO THE PT.

    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 53 YR