BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING ELECTRONICS AND TUBES

    MDR report key: 4020635 · Received July 24, 2014

    Report

    Report Number
    3005677147-2014-00003
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 23, 2014
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MICROTARGETING ELECTRODES ARE SINGLE USE STERILE DEVICES USED IN MICROELECTRODE RECORDING (MER) PROCEDURES WITH A KNOWN ADVERSE EVENT OF HEMORRHAGE. IT IS A FUNCTION OF BRAIN SURGERY AND IS INHERENT TO ITS USE. THIS HEMORRHAGE IS NOT RELATED TO THE FUNCTIONAL ABILITY OF THE MT ELECTRODE USED IN THE INCIDENT. UPDATE FROM PHYSICIAN ((B)(6) 2014) "SHE SPENT 10 DAYS IN THE HOSPITAL AND WAS THEN DISCHARGED TO ACUTE REHAB. SHE REMAINS AT THE ACUTE REHAB, AND WILL LIKELY BE DISCHARGED HOME IN ABOUT 2 WEEKS. SHE HAS REGAINED FUNCTION IN THE LEFT ARM AND LEFT LEG, BUT IS STILL NOT ABLE TO AMBULATE. SHE HAS REGAINED HER SPEECH AND ABILITY TO FEED HERSELF. THE CAUSE OF THE HEMORRHAGE REMAINS UNCLEAR TO ME, AND I DO NOT THINK THAT THERE WAS ANY SPECIFIC WAY THAT THE FHC PRODUCTS COULD BE LINKED TO THE HEMORRHAGE."

    Description of Event or Problem · 1

    (B)(6) SUPPORTED A DBS CASE ON (B)(6) 2014 AT (B)(6) IN WHICH THE PT EXPERIENCED AN INTRACRANIAL HEMORRHAGE. CASE WAS A BILATERAL STN PLATFORM PROCEDURE. DURING THE PROCEDURE THE PT BECAME PROGRESSIVELY LESS RESPONSIVE AND THE PHYSICIAN INDICATED THAT THERE MIGHT BE A HEMORRHAGE. THIS SUSPICION WAS CONFIRMED WHEN THE PHYSICIAN ASKED THE PT TO SMILE AND IT SEEMED THAT SHE COULD ONLY MOVE THE RIGHT SIDE OF HER MOUTH EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435092 MICROTARGETING ELECTRONICS AND TUBES MT ELECTRODE GZL FHC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention