BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD

    MDR report key: 10434428 · Received August 20, 2020

    Report

    Report Number
    2182207-2020-00742
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    June 25, 2020
    Report Date
    August 20, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. GENDER: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MI SUN KIM, HO-SUNG RYU, KYE WON PARK, NARI CHOI, SOOYEOUN YOU, MI-JUNG KIM, YOUNG KIN KIM, JUYEON KIM, KIJU KIM, SUN JU CHUNG. JOURNAL OF NEUROLOGICAL SCIENCE. DOI.ORG/10.1016/J.JNS.2020.117004. INTRODUCTION: LONG-TERM EFFICACY AND SAFETY OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN DBS) IN PATIENTS WITH YOUNG-ONSET PARKINSON'S DISEASE (YOPD) AND LATE-ONSET PD (LOPD) (I.E. MOTOR SYMPTOM INITIAL APPEARANCE AT AGES =40 AND > 40 YEARS, RESPECTIVELY) WAS COMPARED TO IDENTIFY RELATIONSHIPS BETWEEN PD ONSET AGE AND THE EFFICACY OF DBS. METHODS: STATISTICAL ANALYSES COMPARED SPECIFIC MOTOR AND NON-MOTOR FEATURES AMONG 13 PATIENTS WITH YOPD AND 11 WITH LOPD. MEDICATION REDUCTION PATTERNS AND DYSKINESIA SEVERITY SCORES AT BASELINE AND AFTER 1, 3, 5, AND 10 YEARS OF FOLLOW-UP WERE ALSO ANALYZED USING A REPEATED MEASURES ANOVA TESTS. LASTLY, A CORRELATION ANALYSIS IDENTIFIED RELATIONSHIPS BETWEEN THE IMPACT OF DBS SETTINGS (VOLUME OF ACTIVATED TISSUE) AND LEVODOPA EQUIVALENT DAILY DOSE (LED), DYSKINESIA SEVERITY SCORES, UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) PART III, AND UPDRS PART II (DISABILITY) SCORES. RESULTS: TEN YEARS AFTER DBS SURGERY, THE REDUCTION OF LED FROM BASELINE (85.9 ± 592.6 MG VERSUS 623.2 ± 464.9 MG; P = .023) AND LEVODOPA-INDUCED DYSKINESIA (LID) SCORES (UNIFIED DYSKINESIA RATING SCALE [UDYSRS] PARTS III ITEMS 16¿22; 1.6 ± 2.8 VERSUS 5.5 ± 4.1; P = .013) WERE SIGNIFICANTLY LOWER IN YOPD PATIENTS THAN LOPD PATIENTS. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS REGARDING UPDRS PART III SCORE IMPROVEMENT IN RESPONSE TO LEVODOPA, PSYCHOSIS OCCURRENCE, OR ADVERSE EFFECTS. CONCLUSION: TEN YEARS AFTER STN DBS SURGERY, LOPD PATIENTS SHOWED GREATER LED REDUCTION, AND YOPD PATIENTS SHOWED GREATER LID IMPROVEMENT, ALTHOUGH THE GENERAL LONG-TERM OUTCOMES WERE SIMILAR BETWEEN YOPD AND LOPD PATIENTS. PLI 10: IT WAS REPORTED THAT 4 PATIENT'S EXPERIENCED INTRACEREBRAL HEMORRHAGES AFTER THEIR SURGERY. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. IFU: PARKINSON'S DISEASE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899121 LEAD MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other