BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION TREON PLUS

    MDR report key: 1212528 · Received October 24, 2008

    Report

    Report Number
    1723170-2008-00004
    Event Type
    Death
    Date Received
    October 24, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 30, 2008
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE DEVICE IN 2008 REVEALED THAT THE FOOT PEDAL HAS BEEN ACTIVATED WHICH IS A PROVIDED FEATURE FOR FREEZING THE SCREEN TO ALLOW FOR ADJUSTMENT OF IMAGES DURING THE PROCEDURE. SYSTEM WAS FOUND TO BE WITHIN SPECIFICATIONS IN ALL REGARDS.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A CRANIAL TUMOR RESECTION PROCEDURE USING NAVIGATION SYSTEM. IT WAS REPORTED BY A HOSPITAL STAFF MEMBER THAT THE NAVIGATION SCREEN "FROZE" DURING THE PROCEDURE. THE DR ABORTED NAVIGATION, BUT DID NOT ABORT THE PROCEDURE. IT WAS FURTHER REPORTED THAT AFTER THE SURGEON ABORTED NAVIGATION, HE ALLEGEDLY NICKED A VEIN WHICH CAUSED ADDITIONAL BLEEDING. TO REDUCE THE AMOUNT OF BLOOD LOSS, THE SURGEON FINISHED THE PROCEDURE AND CLOSED THE PATIENT AS QUICKLY AS POSSIBLE. IT WAS REPORTED THE DAY FOLLOWING THE PROCEDURE THAT THE PATIENT SUBSEQUENTLY DIED. BY FILING THIS FORM, NO CONCLUSION HAS BEEN DRAWN TO WHAT, IF ANY, CAUSE IS ATTRIBUTABLE TO THE NAVIGATION SCREEN "FREEZING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON PLUS STEREOTACTIC SURGICAL SYSTEM HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death