BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 1056516 · Received June 4, 2008

    Report

    Report Number
    3005677147-2008-00003
    Event Type
    Death
    Date Received
    June 4, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 5, 2008
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K991522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROTARGETING ELECTRODES ARE SINGLE USE DEVICES AND ARE PROVIDED STERILE. THE LOT NUMBER OF THE ELECTRODES USED IS NOT AVAILABLE - THEY WERE DESTROYED BY THE USER FACILITY. THE MICROTARGETING DRIVE, LEKSELL FRAME ADAPTER AND ARRAY INSERTION TUBE SETS ARE DEVICES DESIGNED FOR RE-USE AND MULTIPLE STERILIZATION CYCLES. SURGEON NOTED NO PRODUCT MALFUNCTION OR FAILURE. NO PRODUCT EVALUATED.

    Description of Event or Problem · 1

    BILATERAL THALAMIC DBS PLANNING WAS DONE WITHOUT ISSUE. BEFORE STARTING SURGERY HYPERTENSION WAS NOTED AND NORMALIZED AFTER CLONIDINE ADMINISTRATION. RECORDING AND REGISTRATION ON THE RIGHT SIDE WITH 5 ELECTRODES WAS DONE WITHOUT PROBLEMS. THE DBS LEAD WAS INSERTED AND FIXED. RECORDING AND REGISTRATION ON THE LEFT SIDE WITH 4 ELECTRODES WAS DONE WITHOUT PROBLEMS. DURING MACROSTIMULATION ON THE LEFT SIDE, PT SHOWED A RIGHT HEMI PARALYSIS AND LOST CONSCIOUSNESS. AT THAT MOMENT, HYPERTENSION WAS AGAIN NOTED. THE FINAL DBS LEAD WAS QUICKLY PLACED AND FIXED TO THE BURR HOLE. A CT SCAN SHOWED AN EXTENDED DEEP SEATED BLEEDING IN THE LEFT HEMISPHERE. PT WAS ADMITTED TO INTENSIVE CARE. AN INTENSIVE CARE, HYPERTENSION WAS DIFFICULT TO CONTROL (OBVIOUSLY NOT SECONDARY TO BLEEDING, BECAUSE NO BRADYCARDIA AND NO MASS EFFECT ON CT SCAN). NO INTUBATION BECAUSE OF SUFFICIENT RESPIRATORY FUNCTION. INTUBATION OF PT NEXT DAY DUE TO RESPIRATORY DYSFUNCTION AND ANOTHER CT SCAN SHOWED ENLARGEMENT OF THE BLEEDING. DECISION WAS MADE TO ABSTINATE AND PT DIED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE GZL FHC, INC. 22670

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death MEDTRONIC ARRAY INSERTION TUBE SET MODEL 9033G0621| FHC LEKSELL FRAME ADAPTER MODEL FC1010| MEDTRONIC DEEP BRAIN STIMULATION LEAD| MEDTRONIC MICROTARGETING DRIVE SYS MODEL 9033G0601