BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2935127 · Received January 30, 2013

    Report

    Report Number
    3007566237-2013-00317
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 16, 2012
    Report Date
    January 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ODEKERKEN, V. J. J., VAN LAAR, T., STAAL, M. J., MOSCH, A., HOFFMANN, C. F. E., NIJSSEN, P. C. G., BEUTE, G. N., VAN VUGT, J. P. P., LENDERS, M. W. P. M., CONTARINO, M. F., MINK, M. S. J., BOUR, L. J., CAN DEN MUNCKHOF, P., SCHMAND, B. A., DE HAAN, R. J., SHUURMAN, P. R., DE BIE, R. M. A. (B)(4) STUDY: A RANDOMISED CONTROLLED TRIAL. THE LANCET NEUROLOGY. 2013;12(1):37-44. DOI: 10.1016/S1474-4422(12)70264-8. SUMMARY: PATIENTS WITH ADVANCED PARKINSON'S DISEASE OFTEN HAVE RAPID SWINGS BETWEEN MOBILITY AND IMMOBILITY, AND MANY RESPOND UNSATISFACTORILY TO ADJUSTMENTS IN PHARMACOLOGICAL TREATMENT. WE ASSESSED WHETHER GLOBUS PALLIDUS PARS INTERNA (GPI) DEEP BRAIN STIMULATION (DBS) GIVES GREATER FUNCTIONAL IMPROVEMENT THAN DOES SUBTHALAMIC NUCLEUS (STN) DBS. BETWEEN FEB 1, 2007, AND MARCH 29, 2011, WE ENROLLED 128 PATIENTS, ASSIGNING 65 TO GPI DBS AND 63 TO STN DBS. WE FOUND NO STATISTICALLY SIGNIFICANT DIFFERENCE IN EITHER OF OUR PRIMARY OUTCOMES: MEAN CHANGE IN WEIGHTED ALDS (30 [SD 145] IN THE GPI GROUP VS 77 [232] IN THE STN GROUP; P=028) AND THE NUMBER OF PATIENTS WITH COGNITIVE, MOOD, AND BEHAVIORAL SIDE EFFECTS (36 [58%] OF 62 PATIENTS IN THE GPI GROUP VS 35 [56%] OF 63 PATIENTS IN THE STN GROUP; P=094). SECONDARY OUTCOMES SHOWED LARGER IMPROVEMENTS IN OFF -DRUG PHASE IN THE STN GROUP COMPARED WITH THE GPI GROUP IN THE MEAN CHANGE IN UNIFIED PARKINSON'S DISEASE RATING SCALE MOTOR EXAMINATION SCORES (203 [163] VS 114 [161]; P=003), THE MEAN CHANGE IN ALDS SCORES (203 [271] VS 118 [189]; P=004), AND MEDICATION (MEAN LEVODOPA EQUIVALENT DRUG REDUCTION: 546 [SD 561] VS 208 [521]; P=001). WE RECORDED NO DIFFERENCE IN THE OCCURRENCE OF ADVERSE EVENTS BETWEEN THE TWO GROUPS. OTHER SECONDARY ENDPOINTS SHOWED NO DIFFERENCE BETWEEN THE GROUPS. REPORTED EVENT: 2 PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED IMPLANTATION-SITE INFECTION. FOUR PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED PSYCHOSIS FOR A PERIOD OF THREE MONTHS OR LONGER. FOUR PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED PSYCHOSIS FOR A PERIOD OF THREE MONTHS OR LONGER. ONE PATIENT WHO WAS ALLOCATED TO SUBTHALAMIC NUCLEUS (STN) DBS HAD SURGERY ABORTED DUE TO A LOW THRESHOLD FOR OCULOMOTOR SIDE-EFFECTS DURING MACRO-STIMULATION IN THE STN. THE PATIENT UNDERWENT GLOBUS PALLIDUS PARS INTERNA (GPI) DBS IMPLANT 41 WEEKS LATER BUT HAD A DEEP INTRACEREBRAL HEMORRHAGE DURING SURGERY THAT RESULTED IN HEMIPARESIS. ONE PATIENT IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED PERIOPERATIVE EPILEPSY. TWO PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED POSTOPERATIVE EPILEPSY. ONE PATIENT IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED POSTOPERATIVE EPILEPSY. TWO PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED INFECTION AT THE IMPLANTATION SITE. TWO PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED FACIAL PALSY. FOUR PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED FACIAL PALSY. SIX PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED OCULOMOTOR OR VISUAL FIELD DISTURBANCE. FOUR PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED OCULOMOTOR OR VISUAL FIELD DISTURBANCE. FIVE PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED SENSORY DISTURBANCE. NINE PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED SENSORY DISTURBANCE. TWENTY-THREE PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED BALANCE DISORDER. THIRTY PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED BALANCE DISORDER. ONE PATIENT IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED PARESIS. ONE PATIENT IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED PARESIS. SEVENTEEN PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED DYSKINESIA. TWENTY-FOUR PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED DYSKINESIA. FOURTEEN PATIENTS IMPLANTED IN THE GLOBUS PALLIDUS PARS INTERNA (GPI) EXPERIENCED DELIRIUM. FIFTEEN PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) EXPERIENCED DELIRIUM. 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
    40816 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention