BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7661198 · Received July 3, 2018

    Report

    Report Number
    3007566237-2018-01977
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    May 25, 2018
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KHARKAR, S., ELLENBOGEN, J.R., SAMUEL, M., RIZOS, A., SILVERDALE, M., CHAUDHURI, K.R., ASHAKN, K. CHANGES IN PARKINSON'S DISEASE SLEEP SYMPTOMS AND DAYTIME SOMNOLENCE AFTER BILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE. NPJ PARKINSON'S DISEASE. 2018; 4:16. DOI: 10.1038/S41531-018-0053-5. 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. 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4).

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) MARKEDLY IMPROVES MOTOR FUNCTION IN ADVANCED PARKINSON¿S DISEASE (PD), BUT ITS EFFECT ON SLEEP IS LESS CLEAR. FORTY PD PATIENTS WHO HAD SUBTHALAMIC DBS (STN-DBS) WERE IDENTIFIED FROM AN ONGOING NON-MOTOR NATURALISTIC LONGITUDINAL STUDY (NILS). ALL PATIENTS WERE FOLLOWED UP FOR AT LEAST 6 MONTHS, 26 PATIENTS HAD A 1 YEAR FOLLOW-UP. A TOTAL PDSS SCORE OF 100 OR LESS, A SCORE IN ANY PDSS-ITEM OF 6 OR LESS, AND A EPWORTH SCORE OF 10 OR MORE WERE CLASSIFIED AS BEING SIGNIFICANT. FORTY-FIVE PERCENT OF PATIENTS REPORTED SIGNIFICANT IMPROVEMENT IN THE TOTAL PDSS SCORE AT 6 MONTHS, AND 35% AT 12 MONTHS. IN TERMS OF MAGNITUDE, THE TOTAL PDSS SCORE AT 6 MONTHS WAS SIGNIFICANTLY IMPROVED FROM BASELINE WHILE THE IMPROVEMENT AT 12 MONTHS WAS NOT STATISTICALLY SIGNIFICANT. THE MOST FREQUENTLY REPORTED IMPROVEMENTS WERE OVERALL SLEEP QUALITY AND MAINTENANCE OF SLEEP. SOME PATIENTS REPORTED WORSENING OF THE TOTAL PDSS SCORE. MORE THAN HALF OF THE PATIENTS REPORTING DAYTIME SLEEPINESS AT BASELINE HAD PERSISTENT SLEEPINESS AT 6 AND 12 MONTHS. THE MEAN EPWORTH SCORE DID NOT IMPROVE BECAUSE A SIGNIFICANT NUMBER OF PATIENTS WITHOUT SLEEPINESS AT BASELINE REPORTED NEW-ONSET SLEEPINESS AT 6 AND 12 MONTHS. NEITHER MEDICATION CHANGES NOR MOTOR IMPROVEMENT WERE CONSISTENTLY RELATED TO SLEEP CHANGES AFTER DBS. SUBTHALAMIC DBS IS ASSOCIATED WITH A STATISTICALLY AND CLINICALLY SIGNIFICANT, BUT VARIABLE, IMPROVEMENT IN SLEEP AS MEASURED BY THE PDSS. THE MOST FREQUENT IMPROVEMENTS WERE BETTER OVERALL SLEEP QUALITY AND BETTER SLEEP MAINTENANCE. REPORTED EVENTS: THREE PATIENTS WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) EXPERIENCED WORSENING OF DISTRESSING HALLUCINATIONS AT NIGHT AT 6 MONTHS FOLLOW-UP PER PARKINSON'S DISEASE SLEEP SCALE (PDSS) ITEM 7 SCORE (PDSS-7). IT WAS NOTED THE DECREASE IN DOPAMINERGIC MEDICATIONS WAS MODEST. ONE PATIENTS WITH BILATERAL STN DBS FOR PD EXPERIENCED WORSENING OF DISTRESSING HALLUCINATIONS AT NIGHT AT 12 MONTHS FOLLOW-UP PER PDSS-7 SCORE. IT WAS NOTED THE DECREASE IN DOPAMINERGIC MEDICATIONS WAS MODEST. NO DEVICE SPECIFICS COULD BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502771 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other