BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 5865425 · Received August 10, 2016

    Report

    Report Number
    3007566237-2016-02910
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    January 1, 2016
    Report Date
    August 10, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PT GENDER: PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED AND THE MONTH/YEAR OF THE PUBLICATION OF THE ARTICLE WAS NOTED AS SEPTEMBER 2016, WHICH IS A FUTURE DATE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID 7428, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 7428, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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

    CHAN, D.T., ZHU, C.X., LAU, C.K., POON, T.L., CHEUNG, F.C., LEE, M., TAW, B., HUNG, K.N., CHOI, P., AUYEUNG, M., CHAN, G., CHEUNG, Y.F., CHAN, A.Y.Y., YEUNG, J.H.M., MOK, V.C.T., POON, W.S. SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE IN HONG KONG: A PROSPECTIVE TERRITORY-WIDE 2 YEAR FOLLOW-UP STUDY. WORLD NEUROSURGERY. 2016. 93:229-236. DOI:10.1016/J.WNEU.2016.06.002 SUMMARY: WE ASSESSED THE EFFECTS OF BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) IN PATIENTS WITH PARKINSON DISEASE AT THE 1-YEAR AND 2-YEAR FOLLOW-UP EVALUATIONS. UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) MOTOR SCORE AT ¿OFF¿ MEDICATION (¿ON¿ DBS) AND QUALITY-OF-LIFE ASSESSMENTS (39-ITEM PARKINSON¿S DISEASE QUESTIONNAIRE [PDQ-39]) WERE CONDUCTED. THE PERCENTAGEOF AWAKE ¿ON¿ TIME AND AWAKE ¿OFF¿ TIME AND LEVODOPA REQUIREMENT WERE ALSO ASSESSED. REPORTED EVENTS: 1. 1 PATIENT WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE (PD) HAD THE ENTIRE SYSTEM REMOVED DUE TO AN IMPLANT INFECTION. 2. 1 PATIENT WITH BILATERAL STN DBS FOR PD REQUIRED SURGICAL REVISION OF THE DBS EXTENSION ELECTRODES. THE EXTENSION ELECTRODES CAUSED EXCESSIVE TENSION IN THE PATIENT¿S NECK. THE PATIENT RECOVERED WELL AND WAS ABLE TO COMPLETE FOLLOW-UP AND ASSESSMENTS. 3. 1 PATIENT WITH BILATERAL STN DBS FOR PD REQUIRED SURGICAL REVISION OF THE DBS EXTENSION ELECTRODES. THE PATIENT COMPLAINED OF NEUROPATHIC PAIN IN THE SHOULDER, WHICH WAS CAUSED BY COMPRESSION OF THE SUPRACLAVICULAR NERVE BRANCHES. THE PATIENT RECOVERED WELL AND WAS ABLE TO COMPLETE FOLLOW-UP AND ASSESSMENTS. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389 AND IMPLANTABLE NEUROSTIMULATOR KINETRA MODEL 7428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516498 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention