BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7322296 · Received March 7, 2018

    Report

    Report Number
    3007566237-2018-00687
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    September 14, 2014
    Report Date
    March 9, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATING EVENT TO REFLECT "LIFE-THREATENING" OUTCOME BASED ON ADDITIONAL MEDICAL REVIEW. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. TOMSKIY, A., GAMALEYA, A., GUBAREVA, N., LATYSHEV, Y., KOBYAKOV, G., SHISHKINA, L., PRONIN, I. A CASE OF THALAMIC MALIGNANT GLIOMA FORMATION IN A PATIENT WITH STN-DBS FOR PARKINSON¿S DISEASE. MOV DISORD. 2016;31 (SUPPLEMENT 2): S39. DOI: 10.1002/MDS.26688. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY/REPORTED EVENTS: A (B)(6) MALE WITH THE LEFT-SIDE DOMINANT PD (HOEHN <(>&<)> YAHR STAGE 3) UNDERWENT BILATERAL STN-DBS IN (B)(6) 2008. FOLLOWING THE NEXT SIX YEARS, A STABLE SIGNIFICANT DECREASE IN SEVERITY OF PARKINSONIAN SYMPTOMS, MOTOR FLUCTUATIONS, AND DRUG-INDUCED DYSKINESIA WAS OBSERVED. IN (B)(6) 2014, THEY OBSERVED A PROGRESSIVE DETERIORATION OF NEUROLOGICAL STATE RESULTING IN WEAKNESS OF THE LEFT LIMBS AND UNSTEADY GAIT. TRANSIENT SPEECH DISTURBANCE AND CONFUSION APPEARED IN (B)(6) 2014. MRI REVEALED ANINTRACEREBRAL TUMOR OF THE RIGHT THALAMUS AND CEREBRAL PEDUNCLE AROUND THE LEAD WITH OBSTRUCTIVE HYDROCEPHALY. NEUROLOGICAL EXAMINATION SHOWED PROMINENT ATAXIA, LEFT-SIDED HEMIPARESIS, VERTICAL GAZE PALSY, EXECUTIVE DYSFUNCTION, AND MEMORY IMPAIRMENT. STEREOTACTIC BIOPSY OF THE TUMOR AND VENTRICULO-PERITONEAL SHUNTING WAS PERFORMED SIMULTANEOUSLY. CEREBRAL SYMPTOMS AND BALANCE DISTURBANCES PARTIALLY REGRESSED AFTER SHUNTING. BIOPSY RESULT WAS GLIOBLASTOMA MULTIFORME. SUBSEQUENT RADIO- AND CHEMOTHERAPY WAS SCHEDULED. DBS-SYSTEM WAS NOT EXPLANTED DUE TO PRESERVED STRONG DBS EFFECT AND SIGNIFICANT WORSENING OF PARKINSONIAN SYMPTOMS IN OFF-STIMULATION CONDITION. ETIOLOGY OF GLIOBLASTOMA REMAINS UNCLEAR. CURRENT CLINICAL OBSERVATION ALONE COULD NOT PROVE A RELATIONSHIP BETWEEN DBS AND DEVELOPMENT OF MALIGNANT GLIOMA IN THE AREA OF ELECTRODE IMPLANTATION AND ELECTROSTIMULATION. THE AUTHORS CONCLUDED THAT, MOST LIKELY, THEY OBSERVED TWO INDEPENDENT STATES, ACCIDENTAL CASE OF GLIOBLASTOMA FORMATION IN A DBS-PATIENT. HOWEVER, PROBABILITY OF TUMOR INDUCTION BY ELECTROMAGNETIC FIELD OF DBS-ELECTRODE COULD NOT BE EXCLUDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162779 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R