BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4815754 · Received June 3, 2015

    Report

    Report Number
    3007566237-2015-01537
    Event Type
    Death
    Date Received
    June 3, 2015
    Date of Event
    December 2, 2014
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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 INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, LOT # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    LI, J., ZHANG, Y., LI, Y. LONG-TERM FOLLOW-UP OF BILATERAL SUBTHALAMIC NUCLEUS STIMULATION IN CHINESE PARKINSON'S DISEASE PATIENTS. BRITISH JOURNAL OF NEUROSURGERY. SUMMARY: THE LONG-TERM BENEFITS OF DEEP BILATERALBRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) IN PATIENTS WITH ADVANCED PARKINSON¿S DISEASE (PD) ARE LESS WELL DESCRIBED, ESPECIALLY IN CHINESE COHORTS. HERE, WE PRESENT A LARGE GROUP OF CHINESE PD PATIENTS TREATED WITH BILATERAL STN DBS. BETWEEN 2003 AND 2010, 195 CONSECUTIVE PD PATIENTS RECEIVED IMPLANTS AT THE XUANWU HOSPITAL AFFILIATED TO THE CAPITAL MEDICAL UNIVERSITY IN BEIJING (CHINA) FOR BILATERAL STN DBS. THE MEAN AGE AT IMPLANTATION WAS 58.2 +/- 10.0 YEARS, AND THEY HAD A 5- TO 15-YEAR HISTORY OF PD (MEAN: 6.8 YEARS). PATIENTS WERE ASSESSED WITH THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) AT 1, 3, AND 5 YEARS, BOTH ON AND OFF MEDICATION. EXCEPT FOR SPEECH, PATIENTS¿ OFF-MEDICATION MOTOR FUNCTION SCORES AT 5 YEARS IMPROVED BY 60.3% (P <(><<)> 0.001) AND THOSE FOR ACTIVITIES OF DAILY LIVING IMPROVED BY 54.2% (P <(><<)>0.001). WITH THE EXCEPTION OF DYSKINESIA, ON-MEDICATION MOTOR FUNCTION SCORES DID NOT IMPROVE 1 YEAR AFTER SURGERY. ON-MEDICATION AKINESIA, SPEECH, POSTURAL STABILITY, AND FREEZING OF GAIT WORSENED BETWEEN YEARS 1 AND 5 (ALL P <(><<)> 0.001). AT 5 YEARS, DOPAMINERGIC TREATMENT DOSE AND THE DURATION AND SEVERITY OF LEVODOPA-INDUCED DYSKINESIA WERE REDUCED COMPARED WITH BASELINE (ALL P <(><<)> 0.001). THERE WAS ONE DEATH ASSOCIATED WITH SURGERY TO IMPLANT THE STN DBS. PD PATIENTS WHO WERE TREATED WITH BILATERAL STN DBS EXHIBITED MARKED MOTOR FUNCTION IMPROVEMENTS OVER LONG-TERM FOLLOW-UP WHILE OFF MEDICATION AND IN DYSKINESIA WHILE ON MEDICATION. REPORTED EVENTS: 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE DIEDAFTER DEVELOPING AN INTRAOPERATIVE INTRACEREBRAL HEMORRHAGE AND BECOMING COMATOSE. THE PATIENT DIED TWO WEEKS AFTER SURGERY BECAUSE OF PULMONARY INFECTION. FOUR PATIENTS WERE NOTED TO HAVE DEMENTIA AFTER THE FIFTH YEAR OF FOLLOW-UP. FOUR PATIENTS EXPERIENCED EROSION COMPLICATIONS. MOST OF THESE WERE ASSOCIATED WITH INFECTION, AND IT WAS DIFFICULT TO DETERMINE WHICH OCCURRED FIRST BECAUSE BOTH WERE FREQUENTLY PRESENT AT EVALUATION. EIGHT PATIENTS EXPERIENCED EROSION COMPLICATIONS. MOST OF THESE WERE ASSOCIATED WITH INFECTION, AND IT WAS DIFFICULT TO DETERMINE WHICH OCCURRED FIRST BECAUSE BOTH WERE FREQUENTLY PRESENT AT EVALUATION. IT WAS NOTED THAT THESE INFECTIONS AND/OR EROSIONS OCCURRED AT THE CONNECTOR SITE; THE SIZE OF THE CONNECTOR WAS NOTED TO ¿PROBABLY¿ BE AN IMPORTANT FACTOR. FIVE PATIENTS EXPERIENCED LEAD MIGRATION. IT WAS NOTED THAT THE LEAD MIGRATIONS MAY HAVE BEEN THE RESULT OF CEREBROSPINAL FLUID (CSF) LEAKS. FOUR PATIENTS EXPERIENCED SHORT OR OPEN CIRCUITS. IT WAS NOTED THAT THESE MAY HAVE BEEN THE RESULT OF PATIENTS¿ STRENUOUS ACTIVITIES. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3389 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
    360430 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Death| O| R