BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRIX

    MDR report key: 4380364 · Received January 5, 2015

    Report

    Report Number
    3007566237-2015-00018
    Event Type
    Injury
    Date Received
    January 5, 2015
    Report Date
    December 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE DEVICE WAS USED TO TREAT SEIZURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    KIM, S.H., SON, B.C., LIM, S.C., KIM, W.J., BAE, D.W., SHON, Y.M. EEG DRIVING RESPONSE DURING LOW-FREQUENCY STIMULATION OF ANTERIOR THALAMIC NUCLEUS: IS IT A GOOD PREDICTOR OF THE CORRECT LOCATION OF DBS ELECTRODE? CLINICAL NEUROPHYSIOLOGY. 2013;125(5):1065-1066. DOI:10.1016/J.CLINPH.2013.09.010. SUMMARY/REPORTED EVENTS: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR THALAMIC NUCLEUS (ATN) DEEP BRAIN STIMULATION (DBS) TO CONTROL INTRACTABLE COMPLEX PARTIAL SEIZURES. DURING STIMULATION OF THE LEFT ATN, A CEREBRAL SYNCHRONIZING DRIVING RESPONSE (DR) WAS CLEARLY OBSERVED DURING BIPOLAR STIMULATION BETWEEN CONTACT 0 AND CONTACT 3. STIMULATION OF THE OTHER DBDS ELECTRODE CONTACT PAIRS SHOWED WEAK OR ABSENT DR. THERE WAS, HOWEVER, NO CORTICAL DR FOLLOWING STIMULATION OF THE RIGHT ATN, BUT ¿BIZARRE¿ ELECTRICAL ELECTROENCEPHALOGRAPHY (EEG) ARTIFACTS WERE IDENTIFIED IN THE HIPPOCAMPAL DEPTH ELECTRODES. A POST-OPERATIVE MRI REVEALED THAT THE TRAJECTORY OF THE LEFT DBS ELECTRODE WAS INTACT, BUT THAT THE TIP OF THE RIGHT DBS ELECTRODE HAD MISSED ITS TARGET AND EXTENDED INTO THE LATERAL VENTRICLE. FOLLOWING AN OPERATION TO REPOSITION THE RIGHT DBS ELECTRODE, A CEREBRAL DR WAS CONSISTENTLY OBSERVED ON THE SCALP EEG AND THE RIGHT HIPPOCAMPAL DEPTH EEG. A POST-REPOSITIONING OPERATIVE CT SCAN SHOWED THAT THE SEVERE ELECTRODE ARTIFACTS STILL HAMPERED THE ESTIMATION IF THE RIGHT ELECTRODE WAS PROPERLY INSERTED IN THE RIGHT ATN. DURING EEG MONITORING WITHOUT STIMULATION, FREQUENT EPILEPTIFORM DISCHARGES (EDS) WERE OBSERVED ON THE BILATERAL ANTERIOR HIPPOCAMPAL DEPTH ELECTRODES, BUT NOT ON THE SCALP ELECTRODES. IN ADDITION, ONE OR TWO SESSIONS (FOR SEVERAL HOURS) OF HIGH FREQUENCY STIMULATION ON UNILATERAL OR BILATERAL ATN TO PREDICT THE FORTHCOMING ANTI-SEIZURE EFFECT OF DBS AFTER THE OPERATION. DURING A BILATERAL HIGH-FREQUENCY STIMULATION SESSION OVER FOUR HOURS, THE OCCURRENCE OF HIPPOCAMPAL EDS WAS MARKEDLY REDUCED. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 AND EXTERNAL STIMULATOR MODEL 3628 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4766 MATTRIX STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3628 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention