BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 3905884 · Received May 20, 2014

    Report

    Report Number
    3005677147-2014-00001
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MICROTARGETING ELECTRODES ARE SINGLE USE STERILE DEVICES USED IN MICROELECTRODE REGARDING (MER) PROCEDURES WITH KNOWN ADVERSE EVENTS BUT NOT ONE AS WAS EXPERIENCED DURING THIS SURGERY EVENT. THE SURGEON DID NOT INDICATE THAT ANY OF FHC'S EQUIPMENT CONTRIBUTED TO THE PT'S REACTION AND ALSO ADDED THAT ADDITIONAL TESTS PERFORMED ON THE PT DEMONSTRATED THAT THE PT MAY HAVE EXPERIENCED AN ANXIETY SYNDROME CAUSED BY MEDICATIONS WITHIN THE ANESTHESIA THAT MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    FHC TECHNICIAN IN (B)(6) REPORTED THAT WHILE SHE WAS IN ATTENDANCE AT THE DBS SURGERY IN (B)(6), THE SURGERY STARTED OFF WELL WITH THE FIRST SIDE BUT WHEN THE SURGEON MOVED TO THE SECOND SIDE OF THE BRAIN, THE PT EXPERIENCED AN EXTREME ANXIETY EVENT AND ATTEMPTED TO REMOVE THE SURGICAL EQUIPMENT FROM THEIR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299379 MICROTARGETING ELECTRODE MT ELECTRODE GZL FHC, INC. 34685Z 596871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization