BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2152556 · Received June 27, 2011

    Report

    Report Number
    1723170-2011-01158
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INACCURACY DURING NAVIGATION WAS DUE TO REFERENCE FRAME MOVEMENT BY THE OPERATOR DURING THE MIDDLE OF THE SURGERY, AND NOT A MALFUNCTION OF THE DEVICE. THE SYSTEM WAS EVALUATED AT THE SITE AND FOUND TO BE FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED AN INACCURACY DURING SURGERY WHILE USING THE S7 NAVIGATION SYSTEM. THEY HAD REGISTERED THE PT SUCCESSFULLY, AND NAVIGATION WAS ACCURATE DURING THE FIRST ASPECT OF THE SURGERY. THERE WAS NO IMPACT ON PT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR