BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2539536 · Received April 18, 2012

    Report

    Report Number
    3007566237-2012-00804
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    September 1, 2011
    Report Date
    April 3, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    LITERATURE: DBS CANDIDATES THAT FALL SHORT ON A LEVODOPA CHALLENGE TEST ALTERNATIVE AND IMPORTANT INDICATIONS. TAKASHI MORISHITA, MD, PHD,* MARYAM RAHMAN, MD, MS,* KELLY D. FOOTE, MD, KYLE M. FARGEN, MD, MPH,* CHARLES E. JACOBSON IV, BS,W HUBERT H. FERNANDEZ, MD, RAMON L. RODRIGUEZ, MD,W IRENE A. MALATY, MD,W DAWN BOWERS, PHD,Y CHRISTOPHER J. HASS, PHD, YOICHI KATAYAMA, MD, PHD, TAKAMITSU YAMAMOTO, MD, PHD,Z# AND MICHAEL S. OKUN, MD. THE NEUROLOGIST, VOLUME 17, NUMBER 5, SEPTEMBER 2011. DOI: 10.1097/NRL.0B013E31822D1069. ABSTRACT: INTRODUCTION: CANDIDACY FOR DEEP BRAIN STIMULATION (DBS) IN PARKINSON DISEASE (PD) IS TYPICALLY ASSESSED BY THE PREOPERATIVE MOTOR RESPONSE TO LEVODOPA ALONG WITH AN INTERDISCIPLINARY EVALUATION. HOWEVER, RECENT CASES TREATED AT OUR INSTITUTION HAVE ACHIEVED GOOD OUTCOMES WITH DBS DESPITE A SUB-30% IMPROVEMENT IN MOTOR SCORES. THE AIM OF THIS STUDY WAS TO EXAMINE THE OUTCOMES OF DBS IN A SUBSET OF PATIENTS WHO FAILED TO REACH THE 30% MOTOR IMPROVEMENT THRESHOLD. METHODS: A REVIEW OF ALL DBS PATIENTS TREATED AT THE (B)(6) BETWEEN 2002 AND 2009 WAS PERFORMED UTILIZING A DBS DATABASE. ALL PATIENTS WITH SUB-30% IMPROVEMENT IN UNIFIED PARKINSON DISEASE RATING SCALE PART III AFTER DOPAMINERGIC MEDICATION ADMINISTRATION WERE INCLUDED. RESULTS: NINE PATIENTS WERE IDENTIFIED; DBS WAS PERFORMED FOR SEVERE DYSKINESIA (N = 5), "ON/OFF MOTOR" FLUCTUATIONS (N = 1) AND MEDICATION REFRACTORY TREMOR (N = 3). THE TARGET SYMPTOMS WERE IMPROVED IN ALL PATIENTS. POSTOPERATIVELY, SCORES ON THE UNIFIED PARKINSON DISEASE RATING SCALE PART II AND III AND SUBSCORES ON PARKINSON DISEASE QUESTIONNAIRE-39 IMPROVED (P <(><<)> 0.05). CONCLUSIONS: ALTHOUGH MOTOR RESPONSE TO LEVODOPA REMAINS THE PRIMARY SELECTION CRITERIA FOR DBS CANDIDACY IN PARKINSON DISEASE, PATIENTS WHO DO NOT MEET THE 30% THRESHOLD AND HAVE DISABLING SYMPTOMS MAY STILL BENEFIT FROM DBS. SELECT PATIENTS WITH SEVERE DYSKINESIA, "ON/OFF" MOTOR FLUCTUATIONS, AND/OR MEDICATION-REFRACTORY TREMOR MAY EXPERIENCE SIGNIFICANT BENEFITS FROM DBS AND SHOULD BE CONSIDERED ON A CASE BY CASE BASIS THROUGH AN INTERDISCIPLINARY TEAM EVALUATION. REPORTED EVENT: IT WAS REPORTED THAT ONE PATIENT EXPERIENCED AN INTRA-CEREBRAL HEMORRHAGE (12 MM^3) AROUND THE STN. THE HEMORRHAGE RESULTED IN A TRANSIENT HEMIPARESIS THAT HAD RESOLVED WHEN THE PATIENT RETURNED FOR THE NEUROSTIMULATOR IMPLANTATION 4 WEEKS LATER. 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
    1 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Other LEAD: MODEL UNK, IMPLANT: UNK, EXPLANT: UNK