BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2927556 · Received January 23, 2013

    Report

    Report Number
    3007566237-2013-00267
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    May 23, 2012
    Report Date
    January 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE PATIENT INFORMATION PROVIDED IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BLOMSTEDT, P., FYTAGORIDIS, A., ASTROM, M., LINDER, J., FORSGREN, L., HARIZ, M. I. UNILATERAL CAUDAL ZONA INCERTA DEEP BRAIN STIMULATION FOR PARKINSONIAN TREMOR. PARKINSONISM AND RELATED DISORDERS. 2012;18(10):1062-1066. DOI: 10.1016/J.PARKRELDIS.2012.05.024. SUMMARY: THE SUBTHALAMIC NUCLEUS IS CURRENTLY THE TARGET OF CHOICE IN DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD), WHILE THALAMIC DBS IS USED IN SOME CASES OF TREMOR-DOMINANT PD. RECENTLY, A NUMBER OF STUDIES HAVE PRESENTED PROMISING RESULTS FROM DBSIN THE POSTERIOR SUBTHALAMIC AREA, INCLUDING THE CAUDAL ZONA INCERTA (CZI). THE AIM OF THE CURRENT STUDY WAS TO EVALUATE CZI DBS IN TREMOR DOMINANT PARKINSON'S DISEASE. FOURTEEN PATIENTS WITH PREDOMINATELY UNILATERAL TREMOR-DOMINANT PD AND INSUFFICIENT RELIEF FROM PHARMACOLOGIC THERAPY WERE INCLUDED AND EVALUATED ACCORDING TO THE MOTOR PART OF THE UNIFIED PARKINSON DISEASE RATING SCALE (UPDRS). THE MEAN AGE WAS (B)(6) AND THE DISEASE DURATION 7 +/- 5.7 YEARS. THIRTEEN PATIENTS WERE OPERATED ON WITH UNILATERAL CZI DBS AND 1 PATIENT WITH A BILATERAL STAGED PROCEDURE. FIVE PATIENTS HAD NON-L-DOPA RESPONSIVE SYMPTOMS. THE PATIENTS WERE EVALUATED ON/OFF MEDICATION BEFORE SURGERY AND ON/OFF MEDICATION AND STIMULATION AFTER A MINIMUM OF 12 MONTHS AFTER SURGERY. AT THE FOLLOW-UP AFTER A MEAN OF 18.1 MONTHS STIMULATION IN THE OFF-MEDICATION STATE IMPROVED THE CONTRALATERAL UPDRS III SCORE BY 47.7%. CONTRALATERAL TREMOR, RIGIDITY, AND BRADYKINESIA WERE IMPROVED BY 82.2%, 34.3%, AND 26.7%, RESPECTIVELY. STIMULATION ALONE ABOLISHED TREMOR AT REST IN 10 (66.7%) AND ACTION TREMOR IN 8 (53.3%) OF THE PATIENTS. UNILATERAL CZI DBS SEEMS TO BE SAFE AND EFFECTIVE FOR PATIENTS WITH SEVERE PARKINSONIAN TREMOR. THE EFFECTS ON RIGIDITY AND BRADYKINESIA WERE, HOWEVER, NOT AS PROFOUND AS IN PREVIOUS REPORTS OF DBS IN THIS AREA. REPORTED EVENT: ONE PATIENT DEVELOPED AN INFECTION AT THE INCISION ABOVE THE BURR HOLE FOUR WEEKS AFTER SURGERY. THE ELECTRODE WAS EXPLANTED AND A NEW ONE WAS IMPLANTED THREE MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32605 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention