BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 8706166 · Received June 17, 2019

    Report

    Report Number
    1723170-2019-03488
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    January 30, 2018
    Report Date
    June 17, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: SOFTWARE 9733686 S7 SYNERGY SPINE; UPN (B)(4); 510K K131425. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE ISSUE COULD NOT BE CONFIRMED OR REPLICATED, NO COMPONENTS WERE REPLACED. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE SOFTWARE INVESTIGATION DETERMINED THAT IT WAS NOT POSSIBLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE BEHAVIOR CANNOT BE REPLICATED. THIS CASE MAY BE RE-OPENED IF ADDITIONAL INFORMATION IS RECEIVED. A VIDEO FROM THE CASE WAS RECEIVED AND REVIEWED. REVIEW FOUND THAT THERE WAS MORE THAN ONE INSTRUMENT IN THE FIELD, CAUSING A LARGE JUMP IN THE VIEW POSITION. HAVING TWO INSTRUMENTS IN THE FIELD, THEN REMOVING ONE, WOULD CAUSE THE DESCRIBED BEHAVIOR. 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 BEING USED FOR A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE TRAJECTORY ONE VIEW DURING NAVIGATION WAS DISPLAYING ODD BEHAVIOR. THE ANATOMY WAS 'TWISTING' WHEN IT SHOULDN'T BE, BUT ONLY IN TRAJECTORY 1. CHANGING CROSS-HAIR BEHAVIOR DID NOT RESOLVE THE ISSUE. IT WAS FURTHER REPORTED THAT THE SURGEON TOOK THE INSTRUMENTS OUT OF THE FIELD AND THE BEHAVIOR CONTINUED TO OCCUR. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE AN NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497191 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR