BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3808574 · Received May 13, 2014

    Report

    Report Number
    3007566237-2014-01313
    Event Type
    Death
    Date Received
    May 13, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS THE SPECIFIC PATIENT COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS THE SPECIFIC PATIENT COULD NOT BE IDENTIFIED. THE DATE OF DEATH WAS NOT PROVIDED IN THE ARTICLE; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. 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 MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    KIM, H.J., JEON, B.S., PAEK, S.H., LEE, K.M., KIM, J.Y., LEE, J.Y., KIM, H.J., YUN, J.Y., KIM, Y.E., YANG, H.J., EHM, G. LONG-TERM COGNITIVE OUTCOME OF BILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE. JOURNAL OF NEUROLOGY. 2014. DOI 10.1007/S00415-014-7321-Z SUMMARY: THE EFFECT OF SUBTHALAMIC DEEP BRAIN STIMULATION (STN DBS) ON COGNITION IN PARKINSON¿S DISEASE (PD) REMAINS CONTROVERSIAL, AND IT IS UNCLEAR WHICH FACTORS ARE RELATED TO COGNITIVE DECLINE AND DEMENTIA AFTER STN DBS, ESPECIALLY OVER THE LONG TERM. TO THIS END, WE ANALYZED THE COGNITIVE OUTCOME OF 103 NON-DEMENTED PATIENTS WITH PD WHO WERE FOLLOWED-UP FOR AT LEAST 12 MONTHS AFTER BILATERAL STN DBS SURGERY. PREOPERATIVELY, THE PATIENTS WERE EVALUATED WITH THE UNIFIED PARKINSON¿S DISEASE RATING SCALE AND NEUROPSYCHOLOGICAL TESTS. THE RATE OF GLOBAL COGNITIVE DECLINE AND THE INCIDENCE OF DEMENTIA DURING FOLLOW-UP FOR UP TO 7 YEARS (MEAN 42.4 ± 24.5 MONTHS) WERE CALCULATED, AND PREOPERATIVE CLINICAL AND NEUROPSYCHOLOGICAL FACTORS ASSOCIATED WITH POSTOPERATIVE GLOBAL COGNITIVE DECLINE OR DEMENTIA WERE ANALYZED. THE PREVALENCE OF MILD COGNITIVE IMPAIRMENT (MCI) AND ITS RELATION TO LATER COGNITIVE DECLINE OR DEMENTIA WERE ALSO EVALUATED. THE ANNUAL DECLINE IN THE MINI¿MENTAL STATE EXAMINATION SCORE WAS 0.4 ± 1.7 WITH IMPAIRED ATTENTION AND EXECUTIVE FUNCTION AND A HIGHER LEVODOPA EQUIVALENT DOSE AT BASELINE BEING THE PREDICTORS OF A FASTER GLOBAL COGNITIVE DECLINE AFTER STN DBS. DEMENTIA DEVELOPED IN 13 PATIENTS WITH AN INCIDENCE RATE OF 35.7 PER 1,000 PERSON-YEARS. IMPAIRED EXECUTIVE FUNCTION AT BASELINE PREDICTED DEMENTIA. AT BASELINE, 63.1 % OF THE PATIENTS HAD PD-MCI, AND THESE PATIENTS WERE MORE LIKELY TO DEVELOP DEMENTIA THAN THOSE WITHOUT PD-MCI. THIS STUDY SHOWED THAT DYSFUNCTIONS IN THE FRONTOSTRIATAL CIRCUITRY AT BASELINE WERE ASSOCIATED WITH A RISK OF SUBSEQUENT GLOBAL COGNITIVE DECLINE AND DEMENTIA IN PATIENTS WITH PD WHO UNDERWENT STN DBS. IN ADDITION, PREOPERATIVE PD-MCI WAS A RISK FACTOR FOR DEMENTIA AFTER STN DBS. REPORTED EVENT: ONE PATIENT WITH PARKINSON¿S DISEASE COMMITTED SUICIDE ONE MONTH AFTER SURGERY. THE SOURCE LITERATURE PROVIDED NO SPECIFIC DEVICE INFORMATION. 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
    287055 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Death