BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2063268 · Received March 22, 2011

    Report

    Report Number
    1723170-2011-00700
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFO WAS UNAVAILABLE AT THE TIME OF THIS REPORT. SOFTWARE EVAL IS IN-PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT WHILE IN A SPINAL SURGERY, THE SYSTEM FAILED TO CALIBRATE THE SURETRAK INSTRUMENTS. IT APPEARED THE SYSTEM FREEZES FOR SURETRAK AFTER IT HAD BEEN RE-REGISTERED OR AFTER A CERTAIN AMOUNT OF TIME. THE SOFTWARE STOPS AT THE "CHOOSE DIVOT" STEP. RESTARTING THE SOFTWARE SOLVES THE ISSUE. THEY ARE RUNNING THE SOFTWARE IN (B)(6). REINSTALLATION SHOWS NO SOLUTION. THE SYSTEM TRACKS AND VERIFIES OTHER INSTRUMENTS WITHOUT ISSUE. IT IS JUST THE CALIBRATION OF SURETRAK WHERE THERE IS AN ISSUE. THE SURGEON OPTED TO COMPLETE THE CASE WITHOUT THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.

    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 UNK