BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7392818 · Received April 3, 2018

    Report

    Report Number
    3007566237-2018-00957
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    December 18, 2017
    Report Date
    April 3, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH. 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. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. BARGIOTAS, P., EUGSTER, L., OBERHOLZER, M., DEBOVE, I., LACHENMAYER, ML., MATHIS, J., POLLO, C., SCHUPBACH, WMM., BASSETTI, CL. SLEEP-WAKE FUNCTIONS AND QUALITY OF LIFE IN PATIENTS WITH SUBTHALAMIC DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE. PLOS ONE. 2017;12(12). DOI: 10.1371/JOURNAL.PONE.0190027. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: OBJECTIVES: SLEEP-WAKE DISTURBANCES (SWD) ARE FREQUENT IN PARKINSON'S DISEASE (PD). THE EFFECT OF DEEP BRAIN STIMULATION (DBS) ON SWD IS POORLY KNOWN. IN THIS STUDY WE EXAMINED THE SUBJECTIVE AND OBJECTIVE SLEEP-WAKE PROFILE AND THE QUALITY OF LIFE (QOL) OF PD PATIENTS IN THE CONTEXT OF SUBTHALAMIC DBS. PATIENTS AND METHODS: WE RETROSPECTIVELY ANALYZED DATA FROM PD PATIENTS AND CANDIDATES FOR DBS IN THE NUCLEUS SUBTHALAMICUS (STN). PRE-DBS, SLEEP-WAKE ASSESSMENTS INCLUDED SUBJECTIVE AND OBJECTIVE (POLYSOMNOGRAPHY, VIGILANCE TESTS AND ACTIGRAPHY) MEASURES. POST-DBS, SUBJECTIVE MEASURES WERE COLLECTED. QOL WAS ASSESSED USING THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) AND THE RAND SF-36-ITEM HEALTH SURVEY (RAND SF-36). RESULTS: DATA FROM 74 PD PATIENTS (62% MALE, MEAN AGE 62.2 YEARS, SD = 8.9) WITH A MEAN UPDRSIII (OFF) OF 34.2 (SD = 14.8) AND 11.8 (SD = 4.5) YEARS UNDER PD TREATMENT WERE ANALYZED. PRE-DBS, DAYTIME SLEEPINESS, APATHY, FATIGUE AND DEPRESSIVE SYMPTOMS WERE PRESENT IN 49%, 34%, 38% AND 25% OF PATIENTS RESPECTIVELY BUT NOT ALWAYS AS CO-OCCURRING SYMPTOMS. SLEEP-WAKE DISTURBANCES WERE SIGNIFICANTLY CORRELATED WITH QOL SCORES. ONE YEAR AFTER STN DBS, MOTOR SIGNS, QOL AND SLEEPINESS IMPROVED BUT APATHY WORSENED. CHANGES IN QOL WERE ASSOCIATED WITH CHANGES IN SLEEPINESS AND APATHY BUT BASELINE SLEEP-WAKE FUNCTIONS WERE NOT PREDICTIVE OF STN DBS OUTCOME. CONCLUSION: IN PD PATIENTS PRESENTING FOR STN DBS, SUBJECTIVE AND OBJECTIVE SLEEP-WAKE DISTURBANCES ARE COMMON AND HAVE A NEGATIVE IMPACT ON QOL BEFORE AND AFTER NEUROSURGERY. GIVEN THE CURRENT PRELIMINARY EVIDENCE, PROSPECTIVE OBSERVATIONAL STUDIES ASSESSING SUBJECTIVE AND OBJECTIVE SLEEP-WAKE VARIABLES PRIOR TO AND AFTER DBS ARE NEEDED. REPORTED EVENTS: A PATIENT WHO RECEIVED SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) DEVELOPED A SMALL INTRAPARENCHYMAL BLEED IN THE REGION OF THE LEFT CAPSULA INTERNA. THE EVENT WAS REPORTEDLY SUCCESSFULLY MANAGED POSTOPERATIVELY BUT NO DETAILS REGARDING INTERVENTIONS WERE PROVIDED. 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
    236740 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other