BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4884118 · Received July 1, 2015

    Report

    Report Number
    3007566237-2015-01833
    Event Type
    Death
    Date Received
    July 1, 2015
    Date of Event
    March 26, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THESE DATES ARE BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATE AND DATE OF DEATH WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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 INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. PRODUCT ID 3387 LOT# UNKNOWN; PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    KRONENBUERGER, M., NOLTE, K.W., COENEN, V.A., BURGUNDER, J.M., KRAUSS, J.K., WEIS, J. BRAIN ALTERATIONS WITH DEEP BRAIN STIMULATION: NEW INSIGHT FROM A NEUROPATHOLOGICAL CASE SERIES. MOVEMENT DISORDERS : OFFICIAL JOURNAL OF THE MOVEMENT DISORDER SOCIETY. 2015. DOI: 10.1002/MDS.26247 SUMMARY: PREVIOUS STUDIES ON HUMAN BRAIN TISSUE ALTERATIONS CAUSED BY DEEP BRAIN STIMULATION DESCRIBED GLIAL AND REACTIVE INFLAMMATORY CHANGES. IN THE CURRENT PATHOANATOMICAL STUDY, WE EXTENDED THE ANALYSIS TO SIGNS OF AXONAL CHANGES AND THE INFLUENCE OF CONCOMITANT DISEASE. BRAINS OF 10 PATIENTS WITH PARKINSON¿S DISEASE OR ESSENTIAL TREMOR AND A TOTAL OF 18 ELECTRODES WERE SYSTEMATICALLY EXAMINED UP TO 7.5 Y AFTER SURGERY. IN GENERAL, TISSUE THAT HAD LONG-TERM CONTACT WITH THE ELECTRODE MATERIAL EXHIBITED ASTROGLIOSIS IN ALL, T-LYMPHOCYTES IN 93%, AND MULTINUCLEATED GIANT CELLS IN 68% OF PATIENTS. IMMUNOHISTOCHEMISTRY SHOWED ANINCREASE IN AMYLOID PRECURSOR PROTEIN IMMUNOREACTIVE AXONAL SWELLINGS IN THE BRAIN AT THE ELECTRICALLY ACTIVE PARTS OF THE ELECTRODES. PATIENTS WHO DIED OF SEPTICEMIA SHOWED A MORE SEVRE ASTROGLIOSIS AND GIANT CELL REACTION THAN PATIENTS WHO DIED OF CARDIOVASCULAR EVENTS. PARKINSON¿S DISEASE OR ESSENTIAL TREMOR DID NOT DIFFERENTIALLY PRODUCE HISTOPATHOLOGICAL CHANGES AROUND THE ELECTRODES. LONG-TERM ELECTRICAL STIMULATION BY DEEP BRAIN STIMULATION CAUSES MINOR AXONAL CHANGES. THE CAUSE OF DEATH, BUT NOT THE UNDERLYING NEUROLOGICAL DISEASE, AFFECTS THE HISTOPATHOLOGICAL CHANGES AROUND THE ELECTRODE. THE FINDINGS NEED TO BE REPRODUCED BY EXAMINING LARGER PATIENT SUBGROUPS. REPORTED EVENTS: PATIENT 8: ONE (B)(6) FEMALE PATIENT WITH BILATERAL VENTRAL INTERMEDIAL NUCLEUS (VIM) DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR DIED 15 MONTHS AFTER IMPLANT DUE TO INFECTIOUS DISEASE AND SUBSEQUENT SEPSIS. THE PATIENT REPORTEDLY SHOWED SEVERE ASTROGLISOSIS AND GIANT CELL REACTION. ASTROGLISOSIS, MULTI-NUCLEATED GIANT CELLS (MGNC), LYMPHOCYTES, AND GRANULOCYTES WERE MORE PROMINENT AROUND THE DEEP BRAIN STIMULATION (DBS) TRACTS. THE PATIENT HAD A PROFOUND INFLAMMATORY RESPONSE AROUND THE DBS TRACTS. IT WAS NOTED THAT THE PATIENT¿S BRAIN TISSUE THAT HAD LONG-TERM CONTACT WITH THE DBS ELECTRODE MATERIAL EXHIBITED ASTROGLIOSIS AND AN INFLAMMATORY AND FOREIGN BODY REACTION (CD3-IMMUNOREACTIVE T-LYMPHOCYTES IN 93% AND MULTINUCLEATED GIANT CELLS [MNGC] IN 68% OF PATIENTS). ELEVATED COUNTS OF AMYLOID PRECURSOR PROTEIN (APP)-POSITIVE ENLARGED AXONS OR AXONAL SPHEROIDS WERE MORE PRESENT IN THE DIRECT VICINITY OF THE ACTIVE CONTACTS OF THE DBS ELECTRODES COMPARED WITH THE TISSUE AROUND THE INACTIVE CONTACTS OF THESE ELECTRODES. THE ACCUMULATION OF AXONAL DAMAGE ADJACENT TO THE ACTIVE CONTACTS OF THE DBS ELECTRODES COULD BE CLEARLY DISCERNED FROM THE BACKGROUND. A FEW DIFFUSELY SCATTERED APP-IMMUNOREACTIVE AXONS WERE SEEN. ANTI-TAU (AT8) IMMUNOSTAINING (CLONE AT8) OF SECTIONS CONTAINING THE REGIONS EXPOSED TO THE ELECTRICAL CURRENT ONLY VERY RARELY REVEALED HYPERPHOSPHORYLATED TAU IMMUNOREACTIVITY IN AXONAL STRUCTURES, INCLUDING THE AREAS ADJACENT TO THE DBS TRACT. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 AND IMPLANTABLE NEUROSTIMULATOR MODEL ITREL II, SOLETRA, OR KINETRA. 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
    428084 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death