BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3242998 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02452
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    February 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    CHEN, J., LIU, J.L., CHEN, X., QIAN, H., XIAN,W.B., ZHOU, H.Y., LIU, Y.M., YE,X.F., ZHENG, Y.F., ZHANG, S.L., CHEN, L., LI,J.R., LIU, Z.L., PEI, Z. SIGNIFICANT IMPROVEMENT OF MOTOR SYMPTOMS BY DEEP BRAIN STIMULATION OF BILATERAL SUBTHALAMIC NUCLEUS IN PATIENTS WITH MODERATE OR ADVANCED PARKINSON'S DISEASE. ZHONGHUA YI XUE ZA ZHI. 2011;91(5):291-295. SUMMARY: TO STUDY THE EFFECTS OF DEEP BRAIN STIMULATION (DBS) OF BILATERAL SUBTHALAMIC NUCLEUS (STN) ON THE MOTOR AND NON-MOTOR SYMPTOMS IN MODERATE OR ADVANCED PARKINSON¿S DISEASE (PD) PATIENTS. FROM (B)(6) 2006 TO (B)(6) 2010, 21 CONSECUTIVE PD PATIENTS WITH REFRACTORY MOTOR FLUCTUATIONS OR DYSKINESIA UNDERWENT OPERATIONS AT OUR HOSPITAL. ALL PATIENTS WERE EVALUATED BY UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS), HOEHN <(>&<)> YAHR (H<(>&<)>Y) STAGE, PARKINSON¿S DISEASE QUESTIONNAIRE (PDQ-39), MINI MENTAL STATE EXAMINATION (MMSE), PARKINSON¿S DISEASE SLEEP SCALE-CHINESE VISION (PDSS-CV), PITTSBURGH SLEEP QUALITY INDEX (PSQI), HAMILTON DEPRESSION RATING SCALE (HAMD) AND HAMILTON ANXIETY RATING SCALE (HAMA). THE DAILY DOSAGE OF DOPAMINERGIC AGENTS WAS RECORDED AT 1 WEEK PRE-OPERATION AND 3, 6 AND 12 MONTHS POST-OPERATION. TEN PATIENTS FINISHED A 12-MONTH FOLLOW-UP. THEIR MOTOR FUNCTIONS SHOWED SIGNIFICANT IMPROVEMENT. AND THE SCORES OF UPDRS-MOTOR, TREMOR, RIGIDITY, BRADYKINESIA AND AXIAL SYMPTOMS REDUCED SIGNIFICANTLY IN THE ON-STIMULATION-OFF-MEDICATION CONDITION AND THE ON-STIMULATION-ON-MEDICATION CONDITION VS THE ON-MEDICATION CONDITION PRE-OPERATION. THE IMPROVEMENT OF TREMOR WAS THE MOST PRONOUNCED (52.1% AND 77.7% RESPECTIVELY). THE H<(>&<)>Y STAGE DECREASED SIGNIFICANTLY FROM 3.2 ±0.7 TO 2.5 ± 0.4 POST-OPERATION. THE ACTIVITIES OF DAILY LIVING IMPROVED WHILE PDQ-39 DECLINED SIGNIFICANTLY FROM 56 ±9 PRE-OPERATION TO 32 ± 13 AT 12 MONTHS FOLLOW-UP. THE SCORE CHANGES OF MMSE, PDSS-CV, PSQI, HAMA AND HAMD WERE STATISTICALLY INSIGNIFICANT. THE LEVODOPA EQUIVALENT DOSE OF 1-YEAR POST-OPERATION DECREASED SIGNIFICANTLY BY 49.2% VERSUS THAT OF PRE-OPERATION (P <(><<)> 0.05). REPORTED EVENT: PATIENTS EXPERIENCED EARLY HALLUCINATIONS THAT SPONTANEOUSLY RESOLVED IN THREE DAYS. PATIENT EXPERIENCED MINOR NEEDLE TRACT BLEEDING THAT SHOWED IMPROVEMENT WITH SHORT TERM CONSERVATIVE TREATMENT. PATIENT EXPERIENCED CAPSULAR FLUID THAT SHOWED IMPROVEMENT WITH SHORT TERM CONSERVATIVE TREATMENT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343006 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R