BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHNAVIGATOR ENAV SYSTEM

    MDR report key: 3882268 · Received June 18, 2014

    Report

    Report Number
    1723170-2014-00296
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    February 24, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. PART NOT RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT TOOK PLACE IN (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE CAMERA ARRIVED AT THE DISTRIBUTOR AND WAS TESTED BY THE FIELD REP WITH NO PROBLEMS FOUND. THE SYSTEM PERFORMED AS INTENDED AND THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-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.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, THE INAV PORTABLE CAMERA FELL DURING PRE-OPERATIVE SETUP OF EQUIPMENT, AFTER WHICH THE CAMERA DID NOT WORK. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED AND THE UPCOMING SURGERY WAS PERFORMED SUCCESSFULLY WITHOUT USE OF THE INAV SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358158 STEALTHNAVIGATOR ENAV SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. ENAV

    Patients

    Seq Age Sex Outcome Treatment
    1