BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1993920 · Received January 13, 2011

    Report

    Report Number
    1723170-2011-00040
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT AVAILABLE AT TIME OF THIS REPORT. NO ALLEGATIONS WERE MADE OF MEDTRONIC NAVIGATION'S DEVICE TO HAVE CAUSED OR CONTRIBUTED TO PT EVENT. AS PER THE EVENT DESCRIPTION, IT WAS REPORTED THAT THE PT DIED FROM CIRCUMSTANCES OF THE PT'S PATHOLOGY. THE INVESTIGATION OF THE DEVICE HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THEY WERE TOLD OF AN EVENT INVOLVING THE DEATH OF A PT THAT WAS UNRELATED TO THE USE OF A MEDTRONIC PRODUCT. DURING A CRANIOTOMY FOR TUMOR RESECTION, IT WAS REPORTED THE TUMOR WAS SUPERFICIAL AND ATTACHED TO THE DURA. THE BONE FLAP DID NOT PROPERLY SEPARATE FROM THE DURA AND DISRUPTED A SINUS. AT THAT POINT, THE SURGEON COULD NOT CONTROL THE BLEEDING AND THE PT BLED OUT. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO PT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S TREON SYSTEM THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC'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 UNK