BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2170204 · Received July 5, 2011

    Report

    Report Number
    1723170-2011-01187
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    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

    MEDTRONIC CLINICAL SPECIALIST STATES THAT THERE IS NO REPORTED OR LIKELY RELATIONSHIP BETWEEN THE ADVERSE EVENT AND NAVIGATION; AND THE REPORTED PROBLEM WITH ANESTHESIA AT A CRITICAL JUNCTURE OF SURGERY HAS A CLINICALLY PLAUSIBLE RELATIONSHIP TO MYOCARDIAL EVENT. THEREFORE, NO SYS EVAL IS REQUIRED. NO ALLEGATION WAS MADE OF MEDTRONIC NAVIGATION'S DEVICE CAUSING OR CONTRIBUTING TO THE PT EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REP ATTENDED THE F/U CASE AND PREPARED FOR A NAVIGUS BIOPSY WITH THE SURGEON. THEY COMPLETE THE REGISTRATION AND AS THE SURGEON WAS CREATING THE BURR HOLE, THE PT HAS PROBLEMS WITH ANESTHESIA AND CODED. THE SURGEON HAD TO STOP THE PROCEDURE. THE DECISION OF THE SURGEON IS THAT BECAUSE OF PT HEALTH CONCERNS, THE SURGERY WILL NOT BE RESCHEDULED. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO PT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYS. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S SYS 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 77 YR