BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING PLATFORM

    MDR report key: 1543024 · Received November 20, 2009

    Report

    Report Number
    3005677147-2009-00005
    Event Type
    Injury
    Date Received
    November 20, 2009
    Date of Event
    October 7, 2009
    Report Date
    November 20, 2009
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K003776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL STN-TARGETED PLATFORM BUILT FROM SURGEON PLANNING FILES FOR PATIENT FOR A SURGERY. SURGEON PLANNED ANOTHER, GPI-TARGETED SURGERY FOR THE SAME PATIENT ON EVENT DAY, AND NOTIFIED FHC OF THIS PLAN. A MANUFACTURING TECHNICIAN PRESUMED THE SURGEON WANTED A DUPLICATE STN PLATFORM CREATED. THE SECOND PLATFORM WAS PRODUCED WITH THE SAME PLANNING FILES, BUT INFORMATION ON THE LEG SPECIFYING THE TRAJECTORY WAS CHANGED FROM "STN" TO "GPI". SURGEON USED THE GPI LABELING PLATFORM, AND BASED ON THE INFORMATION PRINTED ON THE PLATFORM LEG PRESUMED HE WAS IN THE GPI LOCATION, WHEN IF FACT IT WAS THE STN LOCATION. INVESTIGATION OF THE MATTER FOUND THAT THERE WERE SEVERAL FACTORS INVOLVED. PRIMARILY THE MANUFACTURING TECHNICIAN MADE AN ASSUMPTION ON THE BUILD OF THE PLATFORM AND DIDN'T VERIFY THAT INFORMATION WITH QC OR THE SURGEON, NOR WAS THE CHANGE DISCUSSED WITH A SUPERVISOR. SECONDLY, FHC DID NOT RECEIVE PLANNING FILES FOR THE GPI TARGET FROM THE SURGEON. FHC HAS NOTIFIED MANUFACTURING TECHNICIANS THAT ANY CHANGE TO A PLATFORM AFTER RECEIPT OF PLANNING FILES FROM THE SURGEON REQUIRES NOTIFICATION AND APPROVAL OF THE SURGEON.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT PATIENT SHOWED RECORDINGS THAT WERE VERY ATYPICAL FOR GPI TARGETING AS INDICATED ON THE MT PLATFORM BUILT FOR THE SURGERY. PATIENT DID NOT UNDERGO DBS IMPLANTATION ,AND SURGERY WAS ABORTED. PATIENT HAD NO SIDE-EFFECTS OF THE SURGERY OTHER THAN THOSE TYPICAL OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING PLATFORM HAW FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention