BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING¿ PLATFORM

    MDR report key: 25305898 · Received May 27, 2026

    Report

    Report Number
    3002250546-2026-00002
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 27, 2026
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    UDI-DI
    00873263005965
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    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

    ON (B)(6), 2026, AN SEEG PROCEDURE WAS PERFORMED WITH 14 PLANNED TRAJECTORIES AND ONE ADDITIONAL GROUND ELECTRODE, WHICH WAS NOT INCLUDED IN THE NAVIGATION PLAN. THE PROCEDURE WAS DELAYED AND BEGAN AT APPROXIMATELY 7:00 PM. MEASUREMENTS WERE PROVIDED INTRAOPERATIVELY FOR BOTH THE TRACKING STYLET AND THE IMPLANTABLE LEAD. THE TRACKING STYLET WAS ADVANCED TO THE INTENDED DEPTH RELATIVE TO THE PLATFORM HUB. IMPLANTABLE LEADS WERE THEN ADVANCED USING DEPTH MARKINGS ON THE LEAD IN CONJUNCTION WITH THE FIXATION BOLT. FOLLOWING PLACEMENT OF ALL LEADS, INTRAOPERATIVE CT IMAGING INDICATED THAT ALL WERE POSITIONED APPROXIMATELY 4-5 CM DEEPER THAN INTENDED. A CONFIRMATORY CT SCAN PERFORMED IN RADIOLOGY VERIFIED THE FINDING. ALL LEADS WERE SUBSEQUENTLY REMOVED. NO INTRACRANIAL HEMORRHAGE WAS IDENTIFIED ON IMAGING. THE PROCEDURE WAS DISCONTINUED AND NOT COMPLETED AS PLANNED. POST-PROCEDURE FOLLOW-UP AT APPROXIMATELY 72 HOURS INDICATED THE PATIENT EXPERIENCED NO ADVERSE EFFECTS OR COMPLICATIONS. THE PHYSICIAN ACKNOWLEDGED OPERATOR USE ERROR AS THE LIKELY CAUSE AND EXPRESSED INTENT TO PURSUE ADDITIONAL TRAINING PRIOR TO FUTURE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497948 MICROTARGETING¿ PLATFORM PLATFORM HAW FHC, INC. MP-KIT-P-EO 00873263005965

    Patients

    Seq Age Sex Outcome Treatment
    1