BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3213622 · Received July 9, 2013

    Report

    Report Number
    1723170-2013-00503
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 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

    SOFTWARE LOG FILES FROM DATE OF EVENT WERE ANALYZED BY ENGINEERING, BUT THE ROOT CAUSE OF THE BEHAVIOR COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL TUMOR RESECTION PROCEDURE, SYNERGY CRANIAL 2.2.6 SOFTWARE UNEXPECTED EXITED WHEN MOVING TO THE MEDTRONIC APPLICATION SCREEN. THE SYSTEM WAS UNRESPONSIVE, HOWEVER, A RE-BOOT RETURNED THE SYSTEM TO PROPER FUNCTION. THE SURGEON COMPLETED THE PROCEDURE WITH NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313502 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR