BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1000101 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00771
    Event Type
    Injury
    Date Received
    February 19, 2008
    Report Date
    November 2, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PATRICK ET AL. "DEEP BRAIN STIMULATION OF THE INTERNAL PALLIDUM IN MULTIPLE SYS ATROPHY - CASE REPORT" PARKINSONISM & RELATED DISORDER/2006/12/181-183. THE ARTICLE IS A CASE STUDY OF A MALE PT WITH MULTIPLE SYS ATROPHY WHO WAS TREATED WITH BILATERAL DBS OF THE INTERNAL PALLIDUM. REPORTABLE EVENT: IN THE FOUR WEEKS POST-OPERATIVELY THERE WAS A MARKED INCREASE IN AKINESIA IN THIS OFF-LABEL USE OF BILATERAL DBS. THIS CONTINUED AND RESULTED IN REDUCTION OF THE OVERALL MOBILITY AS COMPARED TO THE PRE-OPERATIVE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANTABLE EXTENSIONS (2) MODEL UNK| IMPLANTABLE STIMULATOR MODEL UNK| IMPLANTABLE LEAD MODEL UNK