BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3234089 · Received July 18, 2013

    Report

    Report Number
    1723170-2013-00531
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED BY THE MEDTRONIC FIELD REPRESENTATIVE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FROM THE SITE AT THE TIME OF THIS REPORT. SOFTWARE INVESTIGATION NOT COMPLETED. NO FILES/LOGS HAVE BEEN RETURNED TO MANUFACTURER FOR EVALUATION AS YET.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC SOFTWARE ENGINEER ATTEMPTED TO RECREATE THE REPORTED ISSUE WITH THE SUSPECT DATASET, BUT WAS UNABLE TO REPLICATE THE ISSUE. NO RECURRENCE OF ISSUE REPORTED FROM SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A PROCEDURE, THE PATIENT EXAM THE SITE PUSHED OVER THE NETWORK WAS FLIPPED LEFT AND RIGHT. IN TROUBLE-SHOOTING THE SITE REPRESENTATIVE WAS WALKED THROUGH CORRECTING THE EXAM SO THE ORIENTATION WAS CORRECT. REGISTRATION WAS SUCCESSFUL AND ACCURATE. NO FURTHER ISSUES. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333589 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR