BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD

    MDR report key: 10171257 · Received June 18, 2020

    Report

    Report Number
    2182207-2020-00378
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 4, 2020
    Report Date
    June 18, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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

    TAKASHI TSUBOIA, JANINE LEMOS MELO LOBO JOFILI LOPESA, BHAVANA PATELA, JOSEPH LEGACYA, KATHRYN MOOREA, ROBERT S. EISINGERA, LEONARDO ALMEIDAA, KELLY D. FOOTEC, MICHAEL S. OKUNA, ADOLFO RAMIREZ-ZAMORA OBJECTIVE: WE AIMED TO EXPLORE THE DIFFERENCES IN MOTOR SYMPTOMS AND QUALITY OF LIFE (QOL) OUTCOMES FOLLOWING BILATERAL GLOBUS PALLIDUS INTERNUS DEEP BRAIN STIMULATION (GPI DBS), ACROSS WELL-DEFINED MOTOR SUBTYPES OF PARKINSON'S DISEASE (PD), TO IMPROVE CLINICAL DECISION MAKING. METHODS: THIS SINGLE-CENTER RETROSPECTIVE STUDY INVESTIGATED BILATERAL GPI DBS OUTCOMES IN 65 PD PATIENTS. OUTCOME MEASURES INCLUDED THE UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) AND PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) BEFORE AND ONE YEAR AFTER SURGERY. OUTCOMES WERE COMPARED BETWEEN THE TREMOR DOMINANT (TD) AND POSTURAL INSTABILITY AND GAIT DIFFICULTY (PIGD) SUBTYPES AND BETWEEN THE TD AND AKINETIC-RIGID (AR) SUBTYPES. RESULTS: FOR THE ENTIRE COHORT, MOTOR FUNCTION (UPDRS III) IN THE OFF-MEDICATION STATE, MOTOR COMPLICATIONS (UPDRS IV), ACTIVITIES OF DAILY LIVING (ADL, UPDRS II), AND THE ADL AND DISCOMFORT DOMAINS OF PDQ-39 SIGNIFICANTLY IMPROVED ONE YEAR FOLLOWING GPI IMPLANTATION COMPARED TO BASELINE (EFFECT SIZE = 1.32, 1.15, 0.25, 0.45, AND 0.34, RESPECTIVELY). GPI DBS IMPROVED THE OFF-MEDICATION UPDRS III SCORES REGARDLESS OF THE MOTOR SUBTYPES. HOWEVER, COMPARED TO THE PIGD AND AR PATIENTS, THE TD PATIENTS SHOWED GREATER IMPROVEMENT IN OVERALL UPDRS III POSTOPERATIVELY PRIMARILY DUE TO GREATER TREMOR IMPROVEMENT IN THE OFF-MEDICATION STATE. THE OUTCOMES IN AKINESIA, RIGIDITY, AXIAL SYMPTOMS AND QOL WERE SIMILAR AMONG ALL SUBTYPES. CONCLUSION: BILATERAL GPI DBS WAS EFFECTIVE FOR ADVANCED PD PATIENTS REGARDLESS OF MOTOR SUBTYPES. GREATER TREMOR IMPROVEMENT IN THE TD PATIENTS ACCOUNTED FOR GREATER OFF-MEDICATION MOTOR IMPROVEMENT. LONGER-TERM GPI DBS OUTCOMES ACROSS DIFFERENT MOTOR SUBTYPES AND BRAIN TARGETS SHOULD BE FURTHER STUDIED. PLI 2: IT WAS REPORTED THAT FOUR PATIENTS EXPERIENCED LEAD FRACTURES. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL 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
    635118 LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR