BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10117057 · Received June 3, 2020

    Report

    Report Number
    2182207-2020-00291
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 4, 2020
    Report Date
    June 3, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NG JH, SEE AAQ, XU Z, KING NKK. LONGITUDINAL MEDICATION PROFILE AND COST SAVINGS IN PARKINSON'S DISEASE PATIENTS AFTER BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION. J NEUROL. 2020. 10.1007/S00415-020-09741-3 SUMMARY: DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN DBS) HAS BEEN SHOWN TO REDUCE ANTIPARKINSONIAN MEDICATION IN PARKINSON¿S DISEASE. THE AUTHORS AIMED TO INVESTIGATE THE CHANGES IN LONG-TERM MEDICATION PROFILE WITH STN DBS. ANTIPARKINSONIAN MEDICATION DATA FOR 56 PATIENTS WERE COLLECTED FROM AS EARLY AS 3 YEARS BEFORE STN DBS UP TO 10 YEARS AFTER. COST SPENDING ON MEDICATION CHANGES WAS ANALYZED. MEAN LEVODOPA EQUIVALENT DAILY DOSE (LEDD) WAS PROJECTED 10 YEARS INTO THE FUTURE BASED ON PREOPERATIVE DATA TO CREATE A COMPARATOR GROUP WHEREIN THE PATIENTS DID NOT UNDERGO STN DBS. USE OF NEUROLEPTICS AND ANTIDEPRESSANTS WAS ALSO RECORDED. LEDD REQUIREMENT WAS SIGNIFICANTLY REDUCED BY A MEAN OF 31 ± 2% OVER 10 YEARS AFTER DBS, FROM 1049 ± 381 MG AT PRE-DBS BASELINE, TO 713 ± 392 MG AT 1 YEAR POST-DBS, AND 712 ± 385 MG AT 10 YEARS POST-DBS. THIS WAS ASSOCIATED WITH A MEAN REDUCTION OF 35 ± 3% IN MEDICINE COST. MODELED LEDD REQUIREMENTS FOR NOT HAVING STN DBS WERE IN THE RANGE OF 1489 MG TO 2721 MG AT 10 YEARS POST-DBS (109¿282% HIGHER THAN THE OBSERVED MEAN LEDD IN DBS COHORT). THE PROPORTION OF PATIENTS INCREASED FROM 5% BEFORE STN DBS TO 14% AT 10 YEAR POST-DBS FOR NEUROLEPTICS, AND 11¿23% FOR ANTIDEPRESSANTS. STN DBS LED TO LEDD REDUCTION AND ANTIPARKINSONIAN MEDICATION COST SAVINGS IN THE SOUTH-EAST ASIAN COHORT. MEDICATION REDUCTION WITH STN DBS IN THE STUDY COHORT OVER THE 10-YEAR PERIOD WAS COMPARABLE TO THOSE REPORTED IN WESTERN POPULATIONS. REPORTED EVENTS: 8 PATIENTS IMPLANTED FOR SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE EXPERIENCED HARDWARE-RELATED PROBLEMS. THE FOLLOWING DEVICE SPECIFICS WERE IDENTIFIED IN THE LITERATURE ARTICLE: INS MODELS 7428, 37601, 37612; LEAD MODEL 3389.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579907 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1