BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 4232414 · Received November 6, 2014

    Report

    Report Number
    1723170-2014-01192
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. EVENT DATE IS APPROXIMATED AS THE ORIGINAL REPORTER STATED THE EVENT OCCURRED "TWO WEEKS EARLIER" THIS WAS A THIRD-PARTY REPORT TO A MEDTRONIC REPRESENTATIVE. NO PATIENT DEMOGRAPHICS OR FURTHER DETAILS OF THE PATIENT OUTCOME WERE PROVIDED. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS. (B)(6) 2014, A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. (B)(4) 2014, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE ISSUE COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM AN EAR, NOSE & THROAT (ENT) SURGEON ON (B)(6)-2014, THAT WHILE IN A TRANSPHENOIDAL PROCEDURE TWO WEEKS EARLIER, APPROXIMATELY (B)(6)-2014, A PATIENT'S CAROTID ARTERY WAS NICKED. THE SURGEON STATED NAVIGATION HAD BEEN ACCURATE UP TO THAT POINT, THEN ALLEGED THERE WAS, AT THE MOST, A 1MM INACCURACY NAVIGATION. THIS SURGEON WAS REPORTING A CASE PERFORMED BY A NEUROSURGEON. NO FURTHER DETAILS REGARDING THE PATIENT, OR THE PROCEDURE, WERE PROVIDED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE USE OF THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715317 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention