BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 7985609 · Received October 19, 2018

    Report

    Report Number
    1723170-2018-05253
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    November 30, 2017
    Report Date
    October 19, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT EVERYTHING LOOKED FINE. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. MANUFACTURE DATE UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE CAMERA DID NOT RECOGNIZE THE INSTRUMENTS (BOTH PASSIVE AND ACTIVE). NEITHER ADJUSTING THE CAMERA POSITION NOR RESTARTING (TWICE) WOULD RESOLVE THE ISSUE. NAVIGATION WAS ABORTED AND THE PROCEDURE WAS COMPLETED WITH THE IMAGES THEY HAD. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825890 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1