BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 5669845 · Received May 20, 2016

    Report

    Report Number
    3007566237-2016-02060
    Event Type
    Death
    Date Received
    May 20, 2016
    Date of Event
    January 1, 2011
    Report Date
    May 20, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE ACTUAL DATE OF DEATH WAS NOT PROVIDED IN THE LITERATURE ARTICLE; THIS DATE IS BASED ON THE DATE OF ARTICLE PUBLICATION. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN ADDITIONAL SPECIFIC DEVICE INFORMATION SUCH AS SERIAL NUMBERS FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HUGHES, P.S., KRCEK, J.P., HOBSON, D.E., DEL BIGIO, M.R. AN UNUSUAL INFLAMMATORY RESPONSE TO IMPLANTED DEEP BRAIN ELECTRODES. CANADIAN JOURNAL OF NEUROLOGICAL SCIENCES. 2011. 38:1(168-170). SUMMARY: SINCE THE LATE 1980S, DEEP BRAIN STIMULATION (DBS) HAS GAINED INCREASING POPULARITY IN THE TREATMENT OF MOVEMENT DISORDERS AND OTHER CONDITIONS. THE U.S. FOOD AND DRUG ADMINISTRATION APPROVED DBS OF THE THALAMUS FOR THE TREATMENT OF PARKINSON¿S DISEASE AND ESSENTIAL TREMOR IN 1997, AND DBS OF THE SUBTHALAMIC NUCLEUS AND THE GLOBUS PALLIDUS INTERNUS FOR PATIENTS WITH PARKINSON¿S DISEASE IN 2002. DEEP BRAIN STIMULATION HAS ALSO FOUND A ROLE IN THE MANAGEMENT OF DYSTONIA, TOURETTE SYNDROME AND OBSESSIVE-COMPULSIVE DISORDER 2. BY THE END OF 2007, MORE THAN 35,000 PATIENTS WORLDWIDE HAD UNDERGONE DBS THERAPY 3. DESPITE THE LARGE NUMBER OF PROCEDURES, FEWER THAN 50 AUTOPSY REPORTS HAVE DOCUMENTED BRAIN CHANGES ASSOCIATED WITH THE ELECTRODES. IN GENERAL, THE PLACEMENT OF DBS ELECTRODES AND OTHER TYPES OF INVASIVE HARDWARE INTO BRAIN TISSUE IS THOUGHT TO INDUCE ONLY MINOR CHANGES IN THE SURROUNDING PARENCHYMA, TYPICALLY CONSISTING OF MILD ASTROGLIAL AND MICROGLIAL RESPONSES 4. HERE WE REPORT THE AUTOPSY FINDINGS OF A MAN WHO UNDERWENT DBS FOR TREATMENT OF DYSTONIA AND AT THE TIME OF DEATH WAS FOUND TO HAVE DENSE LYMPHOCYTE COLLECTIONS SURROUNDING THE ELECTRODES. REPORTED EVENT; A (B)(6) MAN WITH DEEP BRAIN STIMULATION (DBS) OF THE VENTRAL INTERMEDIATE THALAMIC NUCLEUS (VIM) FOR GENERALIZED DYSTONIC TREMOR EXPERIENCED A SUBSTANTIAL IMPROVEMENT IN TREMOR AND DYSARTHRIA AND HE WAS ABLE TO FOREGO ALL MEDICATION AFTER IMPLANT. THERE WERE NO REPORTED DEVICE OR THERAPY ISSUES THROUGHOUT THE PATIENT¿S TREATMENT; DURING THE ENTIRE TREATMENT PERIOD THE ACTIVE ELECTRODES BILATERALLY WERE THE PROXIMAL (+) AND PENULTIMATE PROXIMAL (-) ELECTRODES. THE INITIAL PARAMETERS WERE PULSE WIDTH (60¿SEC), RATE (130HZ), IMPEDANCE (RIGHT 614 OHMS AND LEFT 793 OHMS), AND CURRENT (RIGHT 70¿A AND LEFT 35¿A). TWO YEARS LATER THE RATE WAS INCREASED TO 160HZ AND THE RIGHT SIDE CURRENT WAS INCREASED TO 105¿A. ONE YEAR LATER THE LEFT SIDE CURRENT WAS INCREASED TO 70¿A. APPROXIMATELY 3 YEARS AFTER IMPLANT IMPEDANCES WERE ~1050 OHMS BILATERALLY. NINE MONTHS LATER AT THE AGE OF (B)(6), THE MAN COLLAPSED AND COULD NOT BE RESUSCITATED FROM VENTRICULAR FIBRILLATION. NO NEUROLOGICAL CHANGES HAD BEEN REPORTED IN THE MONTHS PRIOR TO DEATH. THE AUTOPSY REVEALED A SINGLE FOCUS OF ACTIVE MYOCARDITIS AND MULTIPLE FOCI OF MYOCARDIAL FIBROSIS CONSISTENT WITH HEALED MYOCARDITIS, WHICH MAY HAVE CAUSED AN ARRHYTHMIA. MYOCARDITIS DUE TO VIRAL INFECTION IS A WELL-RECOGNIZED CAUSE OF SUDDEN DEATH. EXCEPT FOR THE ELECTRODE WIRES ENTERING THE FRONTAL LOBES, THE BRAIN (1 ,545G)WAS GROSSLY NORMAL. CORONAL SECTIONS THROUGH THE CEREBRAL HEMISPHERES CONFIRMED THE ELECTRODE POSITION WITHIN BOTH THALAMI, TERMINATING AT THE UPPER MARGIN OF THE SUBTHALAMIC NUCLEI. MICROSCOPIC EXAMINATION OF BRAIN TISSUE SURROUNDING THE LEAD PATHS SHOWED MILD LOSS OF NEURONS, A THIN COLLAGEN SHEATH, RARE REACTIVE ASTROCYTES (DEMONSTRATED BY GLIAL FIBRILLARY ACIDIC PROTEIN (GFAP) IMMUNOSTAINING), AND SMALL COLLECTIONS OF PERIVASCULAR LYMPHOCYTES. ALONG THE MIDDLE ONE CM OF THE RIGHT ELECTRODE ARRAY, LIKELY CORRESPONDING TO BOTH ACTIVE AND INACTIVE ELECTRODES, MULTIPLE FOCI OF PERIVASCULAR LYMPHOCYTES WERE PRESENT. THERE WERE NO MULTINUCLEATE GIANT CELLS AND NO REFRACTILE MATERIAL EVIDENT ON POLARIZED ILLUMINATION. IN THE LEFT THALAMUS A 1.5CM ELECTRODE ARRAY SITE WAS EVIDENT. INFLAMMATION WAS MOST PROMINENT IN THE DORSAL REGION, CORRESPONDING TO ACTIVE ELECTRODE SITES. ON POLARIZED ILLUMINATION VERY RARE MULTI-NUCLEATE GIANT CELLS WITH STREAKS OF REFRACTILE MATERIAL (POSSIBLY POLYURETHANE DEBRIS) WERE IDENTIFIED NEAR THE ELECTRODE TIP IN THE VENTRAL THALAMUS. THESE CELLS WERE SURROUNDED BY COLLAGEN WITH NO LYMPHOCYTES IN THE IMMEDIATE VICINITY. IMMUNOSTAINING SHOWED ROUGHLY EQUAL AND INTERMINGLED POPULATIONS OF CD3 POSITIVE T-LYMPHOCYTES (CD4 GREATER THAN CD8) AND CD20 IMMUNOREACTIVE B-LYMPHOCYTES. IMMUNO-STAINING FOR HUMAN LEUKOCYTE ANTIGEN (HLA-DR) DEMONSTRATED RARE MONOCYTES AMONG THE LYMPHOCYTES AND MICROGLIAL ACTIVATION EXTENDING ~300 MICRONS BEYOND THE ELECTRODES. INFLAMMATION WAS NEGLIGIBLE ALONG THE WIRE PATH. THERE WAS NO EVIDENCE FOR MENINGITIS OR GENERALIZED ENCEPHALITIS EXCEPT FOR A SINGLE SMALL FOCUS OF PERIVASCULAR LYMPHOCYTES IN THE RIGHT CAUDATE NUCLEUS HEAD. LASTLY, IT WAS NOTED THAT IT WAS UNKNOWN TO WHAT EXTENT THE BRAIN INFLAMMATION CONTRIBUTED TO THE MAN¿S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323649 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death