BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 1375263 · Received May 6, 2009

    Report

    Report Number
    3005677147-2009-00002
    Event Type
    Injury
    Date Received
    May 6, 2009
    Date of Event
    February 23, 2009
    Report Date
    April 6, 2009
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K991522
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR REPRESENTATIVE FOLLOWED UP WITH THE SURGEON IN THE CASE. THE SURGEON DID NOT ATTRIBUTE THE INTRACRANIAL BLEED TO ANY DEFECT IN THE ELECTRODE, AND FELT IT WAS A KNOWN POSSIBLE COMPLICATION OF THE SURGERY. THE ELECTRODE WAS NOT RETAINED, AS IT WAS FELT IT WAS NOT THE CAUSE OF THE BLEED. NO FURTHER EVALUATION OF THE PRODUCT IS POSSIBLE.

    Description of Event or Problem · 1

    DISTRIBUTOR REPRESENTATIVE REPORTED THAT DURING MICROELECTRODE RECORDING, PATIENT EXPERIENCED AN INTRACRANIAL BLEED. CASE WAS ABORTED AND PATIENT WAS TAKEN TO CT. PATIENT WAS TRANSFERRED FROM THE HOSPITAL TO A SKILLED NURSING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE GZL FHC, INC. 34680 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization