BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3528608 · Received December 19, 2013

    Report

    Report Number
    1723170-2013-01074
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    October 18, 2011
    Report Date
    November 25, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT WERE NOT PROVIDED IN THE LEGAL DOCUMENT THAT INITIATED THIS REPORT. THE LITIGATION COMPLAINT RELATES TO A: DEVICE THAT PROVIDES STEALTH STATION FLUOROSCOPY INTRAOPERATIVE NAVIGATION FOR SURGERY. AS THE SPECIFIC NAVIGATION SYSTEM WAS NOT IDENTIFIED IN THE LEGAL DOCUMENT AND THERE WAS PREVIOUSLY NO REPORTED ADVERSE EVENT ON THAT DAY, A STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM THAT WAS UTILIZED AT THAT SITE ON THE DAY OF THE REPORTED EVENT, HAS BEEN DOCUMENTED IN THIS 3500A REPORT. NO PARTS OR PATIENT LOGS/EXAMS/ARCHIVES HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS. NO SPECIFIC DETAILS REGARDING THE EVENTS OF THE PROCEDURE, OR THE NAVIGATION SYSTEM, WERE PROVIDED IN THE LEGAL DOCUMENT. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE IS NO DOCUMENTATION THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO PARTS OR PATIENT LOGS/EXAMS RETURNED.

    Description of Event or Problem · 1

    MEDTRONIC NAVIGATION, INC., WAS MADE AWARE OF THIS EVENT ON (B)(6) 2013, VIA A LITIGATION COMPLAINT. THE LITIGATION COMPLAINT DESCRIBES THE NAVIGATION SYSTEM AS A: DEVICE THAT PROVIDES STEALTH STATION FLUOROSCOPY INTRAOPERATIVE NAVIGATION FOR SURGERY; TO CLARIFY, THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM DOES NOT PROVIDE INTRAOPERATIVE FLUOROSCOPY. WITHIN THE NOTICE OF LITIGATION, IT WAS ALLEGED THAT DURING A PROCEDURE TO REMOVE A PITUITARY ADENOMA, THE SURGEON MADE AN INCISION TO THE CAROTID ARTERY, CAUSING LOSS OF BLOOD AND A STROKE. THE NOTICE OF LITIGATION FURTHER STATES THAT FOLLOWING THE SURGERY, THE PLAINTIFF PATIENT SUFFERED PERMANENT INJURY. AS THERE WAS NO PRODUCT MALFUNCTION, AND THE PATIENT'S OUTCOME WAS UNKNOWN AT THAT TIME, THIS EVENT WAS NOT PREVIOUSLY REPORTED. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE IS NO DOCUMENTATION THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664934 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability