BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROELECTRODE

    MDR report key: 4006299 · Received August 5, 2014

    Report

    Report Number
    3005677147-2014-00006
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 3, 2014
    Report Date
    August 1, 2014
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MICRO-TARGETING ELECTRODES ARE SINGLE USE STERILE DEVICES USED IN MICROELECTRODE RECORDING (MER) PROCEDURES WITH A KNOW ADVERSE EVENT OF HEMORRHAGE. IT IS A FUNCTION OF BRAIN SURGERY AND IS INHERENT TO ITS USE. THE INTRACRANIAL BLEEDING IS NOT BELIEVED TO BE RELATED TO THE FUNCTIONAL ABILITY OF THE MT ELECTRODE USED IN THE INCIDENT.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM MEDTRONIC REPRESENTATIVE IN (B)(4). MICROELECTRODE RECORDING (MER) OF THE RIGHT GPI WAS STARTED. RECORDING WAS COMPLETED WITHOUT ANY ISSUES, BUT ABNORMALITY ON THE TIP OF THE MICROELECTRODE WAS CONFIRMED UNDER FLUOROSCOPY BEFORE THE INSERTION OF THE TEST LEAD FOR TEST SIMULATION. THERE WAS A CONCERN OVER POSSIBILITY OF INTRACRANIAL BLEEDING THEREFORE, THE RESPONSE OF THE PATIENT WAS CHECKED AND THERE WAS A REDUCED MOTOR FUNCTION (PARALYSIS). THE PROCEDURE WAS THEREFORE TERMINATED AND THE SITE SUTURED. ACCORDING TO THE PHYSICIAN THERE WAS NOTHING UNUSUAL OTHER THAN THE ABNORMALITY SHOWN ON THE FLUOROSCOPY IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455889 MICROELECTRODE MER ELECTRODE GZL FHC, INC. FC1003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other