BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2196416 · Received July 28, 2011

    Report

    Report Number
    1723170-2011-01223
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATIONS WERE MADE OF MEDTRONIC NAVIGATION'S DEVICE CAUSING OR CONTRIBUTING TO THE PATIENT EVENT. INVESTIGATION OF THE INITIAL IMAGE TRANSFER ISSUE HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT. SHOULD RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT INITIAL IMAGES WERE NOT TRANSFERRING FROM THE O-ARM TO THE STEALTHSTATION, WHILE DISPLAYING GREEN CONNECTION STATUS. RE-BOOTING THE SYSTEM RESOLVED THE ISSUE AND THEY TOOK 2 SPINS FOR THE IMAGES TO TRANSFER OVER TO THE STEALTHSTATION. THERE WAS A MINIMAL 5 MINUTE DELAY. THE MEDTRONIC REPRESENTATIVE REPORTED THAT, UNRELATED TO THE INITIAL ISSUE OF ACQUIRING IMAGES, THE PATIENT LOST 1.5 LITERS OF BLOOD DURING SURGERY. THE SURGEON STOPPED THE CASE BECAUSE, THE PATIENT WAS REPORTEDLY NOT RESPONDING FAVORABLY TO THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. THE PATIENT DIED DURING THE NIGHT DUE TO ANESTHESIA AFFECTS. THERE WAS NO ALLEGED RELATIONSHIP TO THE MNAV EQUIPMENT. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO THE PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    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 40 YR Death O-ARM 1000 IMAGING SYSTEM