BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3984325 · Received August 6, 2014

    Report

    Report Number
    3007566237-2014-02201
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    MEROLA, A., RIZZI, L., ARTUSI, C.A., ZIBETTI, M., RIZZONE, M.G., ROMAGNOLO, A., BERNARDINI, A., LANOTTE, M., LOPIANO, L. SUBTHALAMIC DEEP BRAIN STIMULATION: CLINICAL AND NEUROPSYCHOLOGICAL OUTCOMES IN MILD COGNITIVE IMPAIRED PARKINSONIAN PATIENTS. JOURNAL OF NEUROLOGY. 2014. DOI 10.1007/S00415-014-7414-8. SUMMARY: THIS OBSERVATIONAL STUDY REPORTS THE LONG-TERM FOLLOW-UP OF 184 PARKINSON¿S DISEASE (PD) PATIENTS TREATED WITH SUBTHALAMIC DEEP BRAIN STIMULATION (STN-DBS), RETROSPECTIVELY ANALYZING THE OUTCOMES OF SUBJECTS WITH PRESURGICAL MILD COGNITIVE IMPAIRMENT (MCI) COMPARED TO THOSE OF PATIENTS WITH NORMAL COGNITION. PATIENTS WERE DIVIDED INTO PD-MCI OR NORMAL COGNITION GROUPS AT BASELINE, AND THEN COMPARED AFTER 1, 3, 5 AND[5 YEARS OF FOLLOW-UP. SUBJECTS ASSESSED BY OUTPATIENT CLINICAL FOLLOW-UP EVALUATION, NOT PERFORMING A COMPLETE CLINICAL AND NEUROPSYCHOLOGICAL FOLLOW-UP ASSESSMENT, WERE SEPARATELY CONSIDERED AND RATED ACCORDING TO THEIR FUNCTIONAL AUTONOMY IN DAILY LIVING ACTIVITIES. THE MCI PREVALENCE AT BASELINE WAS 23 %, INCREASING TO 34 % AT 1 YEAR AND OVER 40 % AFTER 3 YEARS. DEMENTIA PROGRESSIVELY AFFECTED MORE THAN 30 % OF SUBJECTS AFTER A MEDIAN TIME OF 6 YEARS IN THE PD-MCI GROUP AND 11 YEARS IN THE NORMAL COGNITION GROUP (P:0.028). THE MORTALITY RISK WAS SLIGHTLY HIGHER IN PD-MCI PATIENTS. OUTPATIENT CLINICAL EVALUATIONS SHOWED A PROGRESSIVE INCREASE OF SUBJECTS COMPLETELY DEPENDENT IN THE ACTIVITIES OF DAILY LIVING, WHICH RANGED FROM THE 11 % AT 3 YEARS TO 23 % AT 5 YEARS AND 31 % AT[5 YEARS. MCI CAN BE FREQUENTLY OBSERVED IN PD PATIENTS, POSSIBLY INFLUENCING THE OUTCOME OF SURGICAL THERAPY. OUR FINDINGS CONFIRM THE SUSTAINED LONG-LASTING EFFICACY OF STN-DBS ON MOTOR FUNCTIONS IN BOTH PD-MCI AND NORMAL COGNITION SUBJECTS. PD-MCI PATIENTS SHOWED A MORE PRECOCIOUS COGNITIVE IMPAIRMENT, AS EXPECTED BY NATURAL HISTORY STUDIES, BUT NO CASE OF DEMENTIA WAS OBSERVED EARLY AFTER SURGERY. REPORTED EVENTS: 1. 12 PATIENTS HAD DEVELOPED PARKINSON¿S ASSOCIATED DEMENTIA AT 3 YEARS POSTOPERATIVELY. 2. LESS THAN 12 PATIENTS HAD DEVELOPED PARKINSON¿S ASSOCIATED DEMENTIA AT 5 YEARS POSTOPERATIVELY. 3. 8 PATIENTS HAD DEVELOPED PARKINSON¿S ASSOCIATED DEMENTIA AT >5 YEARS POSTOPERATIVELY. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    460581 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Other