BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1370905 · Received April 28, 2009

    Report

    Report Number
    2182207-2009-02977
    Event Type
    Injury
    Date Received
    April 28, 2009
    Date of Event
    February 1, 2009
    Report Date
    March 10, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    LITERATURE: GAGO MF, ROSAS MJ, LINHARES P, AYRES-BASTO M, SOUSA G, VAZ R. TRANSIENT DISABLING DYSKINESIAS; A PREDICTOR OF GOOD OUTCOME IN SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE. EUR NEUROL. 2009; 61(2):94-99. SUMMARY: IT WAS REPORTED THAT 5 OUR OF 75 PATIENTS WITH PARKINSON'S DISEASE (PD) THAT SUBMITTED TO SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) DEVELOPED TRANSIENT DISABLING DYSKINESIAS IMMEDIATELY AFTER SURGERY. THE LITERATURE ARTICLE DESCRIBES THE DISTINCTIVE CHARACTERISTICS OF THESE PATIENTS AND COMPARES THEM TO THE REST OF THE PD PATIENTS THAT SUBMITTED TO STN-DBS. THE DYSKINESIA GROUP NEEDED A LOWER LEVODOPA EQUIVALENT DAILY DOSAGE (LEDD) OVER THE TIME OF FOLLOW UP. IT WAS REPORTED THAT DISABLING DYSKINESIAS WAS OBSERVED ONLY AFTER SWITCHING ON THE STIMULATION DESPITE LEVODOPA WITHDRAWAL AND CESSATION OR REDUCTION OF STIMULATION. SURGERY WAS NOT EVENTFUL AND ROUTINE POSTOPERATIVE (6 H AFTER SURGERY) CEREBRAL CT RULED OUT MAJOR ISCHEMIC OR HEMORRHAGIC LESIONS HOWEVER, A MICROLESION OF THE STN COULD HAVE BEEN INVOLVED IN THE ETIOPATHOLOGY OF THE RESULTS. DURING SURGERY, THIS PATIENT PRESENTED GOOD MICRORECORDING AND GOOD MOTOR BENEFIT DURING MICROSTIMULATION. THE PATIENT WAS DISCHARGED 1 WEEK AFTER SURGERY WITH BEARABLE, BUT PERSISTENT DYSKINESIAS. RESOLUTION OF DYSKINESIA WAS SPONTANEOUS, AND TOOK APPROXIMATELY 4 WEEKS. THE PATIENT REQUIRED GRADUAL INCREASES OF STIMULATION VOLTAGE WITHOUT CHANGE TO THE CHOSEN CONTACTS. SEE MANUFACTURER REPORT NUMBER: 2182207200902961.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization IMPLANTED:| LEAD: MODEL LEADMVD| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| EXTENSION: MODEL EXTENSION