BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2550769 · Received April 26, 2012

    Report

    Report Number
    3007566237-2012-00906
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    June 11, 2011
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS.

    Description of Event or Problem · 1

    MEROLA, A., ZIBETTI, M., ANGRISANO, S., RIZZI, L., RICCHI, V., ARTUSI, C., LANOTTE, M., RIZZONE, M. G., LOPIANO, L. PARKINSON'S DISEASE PROGRESSION AT 30 YEARS: A STUDY OF SUBTHALAMIC DEEP BRAIN-STIMULATED PATIENTS. BRAIN. 2011: 134; 2074-2084. CLINICAL FINDINGS IN PARKINSON'S DISEASE SUGGEST THAT MOST PATIENTS PROGRESSIVELY DEVELOP DISABLING NON-LEVODOPA-RESPONSIVE SYMPTOMS DURING THE COURSE OF THE DISEASE. NEVERTHELESS, SEVERAL HETEROGENEOUS FACTORS, SUCH AS CLINICAL PHENOTYPE, AGE AT ONSET AND GENETIC ASPECTS MAY INFLUENCE THE LONG-TERM CLINICAL PICTURE. IN ORDER TO INVESTIGATE THE MAIN FEATURES OF LONG-TERM PARKINSON'S DISEASE PROGRESSION, WE STUDIED A COHORT OF 19 SUBJECTS TREATED WITH SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION AFTER 420 YEARS OF DISEASE, REPORTING CLINICAL AND NEUROPSYCHOLOGICAL DATA UP TO A MEAN OF 30 YEARS FROM DISEASE ONSET. THIS GROUP OF PATIENTS WAS CHARACTERIZED BY AN EARLY ONSET OF DISEASE, WITH A MEAN AGE OF 38.63 YEARS AT PARKINSON'S DISEASE ONSET, WHICH WAS SIGNIFICANTLY LOWER THAN IN THE OTHER LONG-TERM SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FOLLOW-UP COHORTS REPORTED IN THE LITERATURE. ALL SUBJECTS WERE REGULARLY EVALUATED BY A COMPLETE UNIFIED PARKINSON'S DISEASE RATING SCALE, A BATTERY OF NEUROPSYCHOLOGICAL TESTS AND A CLINICAL INTERVIEW, INTENDED TO ASSESS THE RATE OF NON-LEVODOPA-RESPONSIVE SYMPTOM PROGRESSION. CLINICAL DATA WERE AVAILABLE FOR ALL PATIENTS AT PRESURGICAL BASELINE AND AT 1, 3 AND 5 YEARS FROM THE SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION SURGICAL PROCEDURE, WHILE FOLLOW-UP DATA AFTER 47 YEARS WERE ADDITIONALLY REPORTED IN A SUBGROUP OF 14 PATIENTS. THE CLINICAL AND NEUROPSYCHOLOGICAL PERFORMANCE PROGRESSIVELY WORSENED DURING THE COURSE OF FOLLOW-UP; 64% OF PATIENTS GRADUALLY DEVELOPED FALLS, 86% DYSPHAGIA, 57% URINARY INCONTINENCE AND 43% DEMENTIA. A PROGRESSIVE WORSENING OF MOTOR SYMPTOMS WAS OBSERVED BOTH IN "MEDICATION-ON" CONDITION AND IN "STIMULATION-ON" CONDITION, WITH A PARALLEL REDUCTION IN THE SYNERGISTIC EFFECT OF "MEDICATION-ON/STIMULATION-ON" CONDITION. NEUROPSYCHOLOGICAL DATA ALSO SHOWED A GRADUAL DECLINE IN THE PERFORMANCES OF ALL MAIN COGNITIVE DOMAINS, WITH AN INITIAL INVOLVEMENT OF EXECUTIVE FUNCTIONS, FOLLOWED BY THE IMPAIRMENT OF LANGUAGE, REASONING AND MEMORY. THIRTY YEARS AFTER THE DISEASE ONSET, MOST PATIENTS PRESENTED NON-LEVODOPA RESPONSIVE SYMPTOMS, ALTHOUGH THE EFFECT OF BOTH SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION AND DOPAMINERGIC THERAPIES STILL SHOWED SIGNIFICANT EFFICACY ON THE MAIN DISEASE CARDINAL FEATURES. NEVERTHELESS, COMPARED WITH OTHER SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FOLLOW-UP STUDIES, WHICH INCLUDED PATIENTS WITH A SHORTER DISEASE DURATION AT THE TIME OF SURGERY, A HIGHER PREVALENCE OF AXIAL AND NON-LEVODOPA-RESPONSIVE SYMPTOMS WAS OBSERVED IN THE LONG-TERM EVALUATIONS, CONFIRMING THAT SEVERAL COMPLEX ASPECTS UNDERLIE THE DEVELOPMENT OF NON-MOTOR SYMPTOMS AND OTHER FEATURES OF PARKINSON'S DISEASE PROGRESSION, EVEN IN PATIENTS WITH AN EARLY DISEASE ONSET AND A PRIOR LONG-LASTING RESPONSE TO DOPAMINERGIC THERAPIES. REPORTED EVENT: AT > 7 YEARS FOLLOWING STN DBS, A TOTAL OF 5 PATIENTS WERE EXPERIENCING POSTURAL HYPOTENSION REQUIRING PHARMACOLOGICAL TREATMENT. AT > 7 YEARS FOLLOWING STN DBS, A TOTAL OF 7 PATIENTS WERE EXPERIENCING CONSTIPATION REQUIRING PHARMACOLOGICAL TREATMENT. AT > 7 YEARS FOLLOWING STN DBS, A TOTAL OF 3 PATIENTS WERE EXPERIENCING SEVERE DYSPHAGIA REQUIRING PERCUTANEOUS GASTROSTOMY. AT 5 YEARS FOLLOWING STN DBS, A TOTAL OF 9 PATIENTS WERE EXPERIENCING DEMENTIA. AT 5 YEARS FOLLOWING STN DBS, A TOTAL OF 8 PATIENTS WERE EXPERIENCING MOOD DEPRESSION REQUIRING PHARMACOLOGICAL TREATMENT. AT 5 YEARS FOLLOWING STN DBS, A TOTAL OF 9 PATIENTS WERE EXPERIENCING HALLUCINATIONS REQUIRING PHARMACOLOGICAL TREATMENT. AT 5 YEARS AFTER STN DBS, A TOTAL OF 8 PATIENTS EXPERIENCED A SIGNIFICANT IMPAIRMENT IN REASONING. AT 5 YEARS AFTER STN DBS, A TOTAL OF 4 PATIENTS EXPERIENCED A SIGNIFICANT IMPAIRMENT IN MEMORY. AT 5 YEARS AFTER STN DBS, A TOTAL OF 9 PATIENTS EXPERIENCED A SIGNIFICANT IMPAIRMENT IN EXECUTIVE FUNCTIONS. AT 5 YEARS AFTER STN DBS, A TOTAL OF 8 PATIENTS EXPERIENCED A SIGNIFICANT IMPAIRMENT IN LANGUAGE. 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
    1 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention LEAD MODEL UNKNOWN