BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROTARGETING¿ ELECTRODE

    MDR report key: 21295201 · Received February 3, 2025

    Report

    Report Number
    3002250546-2025-00001
    Event Type
    Death
    Date Received
    February 3, 2025
    Date of Event
    January 2, 2025
    Report Date
    February 3, 2025
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    UDI-DI
    00873263002674
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FHC IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY FHC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. FHC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, FHC, OR ITS EMPLOYEES THAT THE DEVICE, FHC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. FHC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    A CASE WAS COMPLETED ON (B)(6) 2025 AT (B)(6) MEDICAL CENTER, (B)(6) WITH DR. (B)(6), WHERE A 57 Y/O PATIENT HAD BOSTON SCIENTIFIC LEADS IMPLANTED BILATERALLY IN STN. MER WAS PERFORMED ON BOTH HEMISPHERES SIMULTANEOUSLY USING FHC 44975Z MICROELECTRODES (A SINGLE TRACK PER SIDE) AND A GUIDELINE 4000 LP+ SYSTEM. OTHER FHC PRODUCTS USED DURING THE CASE WERE STARFIX PLATFORM, 66-IT-03P INSERTION TUBES, 66-ST-12P STYLET. PATIENT RESPONDED WELL TO STIMULATION AND O-ARM IMAGING SHOWED ACCURATE TARGETING. POST-OP CT SHOWED NO ABNORMALITIES AND PATIENT WAS DISCHARGED THE SAME DAY OF SURGERY. THE PATIENT WAS DOING WELL AND HAD GONE BACK TO WORK. FACILITY DID NOT RETAIN LOT# OF PRODUCT USED AND DISPOSED OF PRODUCTS. ON 01/16/2025 FHC, INC. REPRESENTATIVE WAS ATTENDING ANOTHER CASE AT (B)(6) MEDICAL CENTER WITH DR. (B)(6) WHERE DURING THE CASE, THE DR. INFORMED THE FHC REP, THAT THE PATIENT THEY OPERATED ON (B)(6) 2025 WAS FOUND DEAD THIS WEEK AND THAT THEY WERE GOING TO CONDUCT AN AUTOPSY TO DETERMINE THE CAUSE OF DEATH. THE AUTOPSY WAS CONDUCTED ON (B)(6) 2025 WHERE AN INTRACEREBRAL HEMORRHAGE (ICH) AT DBS-LEAD ENTRY SITE AND THALAMUS WAS DETERMINED TO BE CAUSE OF DEATH. SINCE POST-OP CT WAS CLEAR, IT WAS CONSIDERED A DELAYED ICH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295009 MICROTARGETING¿ ELECTRODE ELECTRODE GZL FHC, INC. 44975Z-00267 UNKNOWN 00873263002674

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death