BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2453302 · Received February 15, 2012

    Report

    Report Number
    3007566237-2012-00328
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    June 10, 2011
    Report Date
    January 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED: UNK, EXPLANTED: UNK. LEAD: MODEL 3387, LOT# UNK, SERIAL# UNK, IMPLANTED: UNK, EXPLANTED: UNK. IPG MODEL: 7428, 7426 OR 7424. THIS DATE IS AN ESTIMATE BASED ON THE DATE THE ARTICLE WAS SUBMITTED. ACTUAL EVENT DATE IS UNKNOWN. 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 THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: TEN-YEAR OUTCOME OF SUBTHALAMIC STIMULATION IN PARKINSON DISEASE A BLINDED EVALUATION ANNA CASTRIOTO, MD; ANDRES M. LOZANO, MD, PHD; YU-YAN POON, RN; ANTHONY E. LANG, MD; MELANIE FALLIS, RN; ELENA MORO, MD, PHD. ARCH NEUROL. 2011;68(12):1550-1556. PUBLISHED ONLINE AUGUST 8, 2011. DOI:10.1001/ARCHNEUROL.2011.182. OBJECTIVE: TO ASSESS THE 10-YEAR MOTOR OUTCOME OF DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STNDBS) IN PATIENTS WITH PARKINSON DISEASE (PD). DESIGN: PATIENTS WITH PD WITH BILATERAL STN-DBS WERE ASSESSED ACCORDING TO THE CORE ASSESSMENT PROGRAM FOR SURGICAL INTERVENTIONAL THERAPIES IN PARKINSON¿S DISEASE PROTOCOL AND VIDEOTAPED AT BASELINE AND 1, 5, AND 10 YEARS AFTER SURGERY. AN INDEPENDENT RATER BLINDED TO STIMULATION AND MEDICATION CONDITION SCORED THE 10YEAR VIDEO ASSESSMENTS. PATIENTS: EIGHTEEN PATIENTS WITH ADVANCED PD AND 10 YEAR FOLLOW-UP OF STN-DBS. INTERVENTION: BILATERAL STN-DBS SURGERY. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS THE CHANGE IN BLINDED UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) MOTOR SCORES/SUBSCORES BETWEEN THE NO MEDICATION/STIMULATION CONDITION VS THE NO MEDICATION/NO STIMULATION CONDITION AT 10 YEARS. SECONDARY OUTCOMES WERE THE CHANGES IN BLINDED UPDRS MOTOR SCORES BETWEEN THE MEDICATION/NO STIMULATION AND MEDICATION/STIMULATION CONDITIONS, UPDRS II SCORES, UPDRS IV DYSKINESIA AND MOTOR FLUCTUATIONS SCORES, AND ANTI-PD MEDICATION DOSE (LEVODOPA EQUIVALENT DAILY DOSE) AT DIFFERENT POINTS. RESULTS: IN THE 18 PATIENTS AVAILABLE FOR FOLLOW-UP AT 10 YEARS, STN-DBS STILL SIGNIFICANTLY IMPROVED THE UPDRS TOTAL MOTOR SCORE (P=.007) AND RESTING AND ACTION TREMOR (P=.01 AND P=.02, RESPECTIVELY) AND BRADYKINESIA (P=.01) SUBSCORES. THE UPDRS II SCORES IN THE MEDICATION AND NO MEDICATION CONDITIONS, UPDRS IV DYSKINESIA AND MOTOR FLUCTUATIONS SCORES, AND THE LEVODOPA EQUIVALENT DAILY DOSE WERE ALSO SIGNIFICANTLY REDUCED COMPARED WITH BASELINE. AXIAL SIGNS SHOWED THE MOST PROGRESSIVE DECLINE IN STIMULATION AND LEVODOPA RESPONSE OVER THE YEARS. CONCLUSION: THIS CLASS III STUDY PROVIDES EVIDENCE THAT STIMULATION-INDUCED MOTOR IMPROVEMENT WAS SUSTAINED OVERALL AT 10 YEARS, ALTHOUGH PART OF THE INITIAL BENEFIT WORE OFF MAINLY BECAUSE OF PROGRESSIVE LOSS OF BENEFIT ON AXIAL SIGNS OVER TIME. REPORTABLE EVENTS: TWO PATIENTS DEVELOPED DEVICE-RELATED INFECTIONS BETWEEN 5 AND 10 YEARS AFTER SURGERY. ONE PATIENT HAD THE RIGHT ELECTRODE REMOVED 7 YEARS AFTER SURGERY, AND THE ONE PATIENT HAD THE RIGHT INTERNAL PULSE GENERATOR REMOVED. ONE PATIENT ATTEMPTED SUICIDE. IT WAS NOTED THAT MOST NEUROPSYCHIATRIC ISSUES OCCURRED AND WERE SOLVED DURING THE FIRST TWO YEARS AFTER SURGERY. FOUR PATIENTS EXPERIENCED DEPRESSION. IT WAS NOTED THAT MOST NEUROPSYCHIATRIC ISSUES OCCURRED AND WERE SOLVED DURING THE FIRST TWO YEARS AFTER SURGERY. FIVE PATIENTS DEVELOPED VISUAL HALLUCINATIONS AFTER THE 5-YEAR FOLLOW-UP. SEE ATTACHED LITERATURE ARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention LEAD: MODEL 3387, LOT# UNK, SERIAL# UNK