BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD

    MDR report key: 10590959 · Received September 26, 2020

    Report

    Report Number
    2182207-2020-00959
    Event Type
    Injury
    Date Received
    September 26, 2020
    Date of Event
    July 27, 2020
    Report Date
    September 25, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: 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

    KYE WON PARKA, SUNGYANG JOA, MI SUN KIMA, NARI CHOIA, SANG RYONG JEONB, HEE KYUNG PARKC, KYUM-YIL KWOND, CHONG S. LEEA, SUN JU CHUNGA. HTTPS://DOI.ORG/10.1016/J.JNS.2020.117063. BACKGROUND: ALTHOUGH DEMENTIA IS A CONTRAINDICATION FOR DEEP BRAIN STIMULATION (DBS) IN PATIENTS WITH PARKINSON'S DISEASE (PD), THE CONCEPT IS SUPPORTED BY LITTLE SCIENTIFIC EVIDENCE. MOREOVER, IT IS UNCLEAR WHETHER PD WITH MILD COGNITIVE IMPAIRMENT (PD-MCI) OR DOMAIN-SPECIFIC COGNITIVE IMPAIRMENTS AFFECT THE OUTCOME OF DBS IN NON-DEMENTED PD PATIENTS. OBJECTIVE: TO INVESTIGATE THE INFLUENCE OF BASELINE COGNITIVE PROFILES OF PD ON THE OUTCOME OF DBS. METHODS: BASELINE COGNITIVE LEVELS OF PATIENTS WITH PD WHO UNDERWENT DBS WERE CLASSIFIED INTO PD WITH DEMENTIA (PDD) (N=15), PD-MCI (N=210), AND NORMAL COGNITION (PD-NC) (N=79). THE IMPACT OF THE COGNITIVE LEVEL ON KEY DBS OUTCOME MEASURES [MORTALITY, NURSING HOME ADMISSION, PROGRESSION TO HOEHN<(>&<)>YAHR (HY) STAGE 5 AND PROGRESSION TO PDD] WERE ANALYZED USING COX REGRESSION MODELS. WE ALSO INVESTIGATED WHETHER IMPAIRMENT OF A SPECIFIC COGNITIVE DOMAIN COULD PREDICT THESE OUTCOMES IN NON-DEMENTED PATIENTS. RESULTS: PATIENTS WITH PDD SHOWED A SUBSTANTIALLY HIGHER RISK OF NURSING HOME ADMISSION AND PROGRESSION TO HY STAGE 5 COMPARED WITH PATIENTS WITH PD-MCI [HAZARD RATIO (HR) 4.20, P=.002; HR=5.29, P <(><<)> .001] AND PDNC (HR 7.50, P <(><<)> .001; HR=7.93, P <(><<)> .001). MCI DID NOT ALTER THE PROGNOSIS IN PATIENTS WITHOUT DEMENTIA, BUT THOSE WITH VISUOSPATIAL IMPAIRMENT SHOWED POORER OUTCOMES FOR NURSING HOME ADMISSION (P=.015), PROGRESSION TO HY STAGE 5 (P=.027) AND PDD (P=.006). CONCLUSIONS: COGNITIVE PROFILES MAY STRATIFY THE PRE-OPERATIVE RISK AND PREDICT LONG-TERM OUTCOMES OF DBS IN PD. REPORTED EVENTS: PLI 10: IT WAS REPORTED THAT 11 PATIENTS HAD EITHER A LEAD REMOVAL OR LEAD REVISION PLI 20: IT WAS REPORTED THAT 13 PATIENTS HAD DBS-RELATED HEMORRHAGE. IT WAS NOT POSSIBLE TO ASCERTAIN 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
    1055489 LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R