BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5534890 · Received March 30, 2016

    Report

    Report Number
    3007566237-2016-01524
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    February 1, 2016
    Report Date
    March 30, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE/DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE ¿NON-MUTATION CARRIER (NC)¿ COHORT PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PT SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE ¿NON-MUTATION CARRIER (NC)¿ COHORT PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OFEVENT: 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SAYAD, M., ZOUAMBIA, M., CHAOUCH, M., FERRAT. F., NEBBAL, M., BENDINI, M., LESAGE, S., BRICE, A., ERRAHMANI, M.B., ASSELAH, B. GREATER IMPROVEMENT IN LRRK2 G2019S PATIENTS UNDERGOING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION COMPARED TO NON-MUTATION CARRIERS. BMC NEUROSCIENCE. 2016. 17(1):6.10.1186/S12868-016-0240-4 SUMMARY: BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) OF PARKINSON¿S DISEASE (PD) PATIENTS HAS DEMONSTRATED TO IMPROVE MOTOR PERFORMANCE AND TO REDUCE DOPA-INDUCED DYSKINESIA. AN ASSOCIATION BETWEEN THE OCCURRENCE OF DYSKINESIAS AND LRRK2 (LEUCINE-RICH REPEAT KINASE 2) G2019S GENE MUTATIONS HAS RECENTLY BEEN SUGGESTED. THE AIM OF THIS STUDY IS TO DISCOVER THE IMPACT OF THE G2019S MUTATION (WITH HIGH INCIDENCE IN THE AUTHORS¿ NATIVE ALGERIA) ON THE SYMPTOM RESPONSE OF PD IN PATIENTS WHO UNDERWENT STN-DBS. REPORTED EVENTS FOR NON-MUTATION CARRIER (NC) PATIENTS: 2 PATIENTS WHO WERE NON-MUTATION CARRIERS (NC) WITH BILATERAL DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN-DBS) FOR PARKINSON'S DISEASE (PD) EXPERIENCED A STIMULATOR INFECTION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. FOLLOW-UP TO THE ARTICLE¿S CORRESPONDING AUTHOR HAS BEEN REQUESTED FOR ADDITIONAL/MISSING EVENT INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191107 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Other