BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2362258 · Received December 7, 2011

    Report

    Report Number
    3007566237-2011-09191
    Event Type
    Injury
    Date Received
    December 7, 2011
    Report Date
    November 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    LITERATURE: WITT, K., DANIELS, C., KRACK, P., VOLKMANN, J., PINSKER, M. O., KLOSS, M., TRONNIER, V., SCHNITZLER, A., WOJTECKI, L., BOTZEL, K., DANEK, A., HILKER, R., STURM, V., KUPSCH, A., KARNER, E., DEUSCHL, G. NEGATIVE IMPACT OF BORDERLINE GLOBAL COGNITIVE SCORES ON QUALITY OF LIFE AFTER SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSON'S DISEASE. JOURNAL OF THE NEUROLOGICAL SCIENCES. 2011. 310: 261-266. AVAILABLE ONLINE JULY 5, 2011. DOI: (B)(6). SUMMARY: THE AUTHORS REPORT ON THE CHANGE IN QUALITY OF LIFE (QOL) OF PATIENTS WITH DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN-DBS) AND PATIENTS THAT UNDERWENT BEST MEDICAL TREATMENT (BMT). A TOTAL OF 60 PATIENTS WERE ANALYZED IN THE STN-DBS GROUP AND 59 PATIENTS IN THE BMT GROUP. QOL SCORES WERE ASSESSED AT BASELINE AND AT 6 MONTHS FOLLOW UP USING THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39). PATIENTS WERE SPLIT INTO FOUR GROUPS ACCORDING TO THEIR PERFORMANCE ON THE MATTIS DEMENTIA RATING SCALE (MDRS) AT BASELINE AND THESE GROUPS WERE COMPARED IN THE CONTEXT OF MOTOR OUTCOME AND QOL. REPORTED EVENT: FOUR PATIENTS EXPERIENCED PSYCHOSIS. FURTHER INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE IN MFR REPORT # 3007566237-2011-09184.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEADS MODELS UNKNOWN, LOT#S UNKNOWN