BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT, STEREOTAXIC

    MDR report key: 10596005 · Received September 28, 2020

    Report

    Report Number
    1723170-2020-02549
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    September 10, 2020
    Report Date
    September 28, 2020
    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

    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 THAT WAS USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT ONE LED LIGHT OF THE ACTIVE SHARP PROBE WAS NOT VISIBLE. MAGNITUDE AND DIRECTION OF INACCURACY WAS REPORTED TO BE 2-3MM UPWARD SHIFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A PASSIVE PROBE INSTEAD. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR. THERE IS NO KNOWN IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE WAS UNKNOWN, BUT IT WAS SUSPECTED TO BE DUE TO A FRACTURE IN THE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060250 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733880 081014

    Patients

    Seq Age Sex Outcome Treatment
    1