BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHNAVIGATOR ENAV SYSTEM

    MDR report key: 3754577 · Received April 16, 2014

    Report

    Report Number
    1723170-2014-00385
    Event Type
    Death
    Date Received
    April 16, 2014
    Date of Event
    March 19, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON (B)(4) 2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE MANUFACTURING DATE WAS UNAVAILABLE AT THIS TIME. THE HARDWARE AND SOFTWARE PASSED THE SYSTEM CHECKOUT. THE SYSTEM PERFORMED AS INTENDED AND THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. AS REPORTED BY THE SURGEON, THERE WAS NO MALFUNCTION OF THE DEVICE. THE PATIENT DIED AS A RESULT OF THE SURGERY WHICH WAS UNRELATED TO THE USE OF THE DEVICE. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTH INAV PORTABLE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A TUMOR RESECTION PROCEDURE, THE SURGEON WAS ABLE TO RETRIEVE A TUMOR SAMPLE, HOWEVER, THE TUMOR WAS FOUND TO BE VERY VASCULAR CAUSING THE PATIENT TO BLEED OUT AND DIE. THE MEDTRONIC REPRESENTATIVE REPORTED THAT THERE WAS NO ALLEGED DEFICIENCY AND/OR INACCURACY OF THE MEDTRONIC NAVIGATION SYSTEM. THE SURGEON WAS PLEASED WITH PATIENT REGISTRATION AND WAS ACCURATE THROUGHOUT THE SURGERY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED A MEDTRONIC NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT THE MEDTRONIC NAVIGATION DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231793 STEALTHNAVIGATOR ENAV SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. ENAV

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death