BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1019058 · Received March 24, 2008

    Report

    Report Number
    2182207-2008-01526
    Event Type
    Injury
    Date Received
    March 24, 2008
    Report Date
    November 27, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: TIR ET AL. "EXHAUSTIVE, ONE-YR F/U OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN A LARGE, SINGLE-CENTER COHORT OF PARKINSONIAN PTS." 2007/61/2/97-304. THIS ARTICLE DESCRIBES A STUDY THAT ENROLLED CONSECUTIVE PTS WITH PARKINSON'S DISEASE WHO WERE TREATED WITH BILATERAL STN-DBS. THE PTS WERE FOLLOWED FOR A PERIOD OF 12 MOS. REPORTABLE EVENT: SOME PTS HAD A LEAD REPOSITIONED DUE TO UNSATISFACTORY CLINICAL RESULTS.

    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 UNK Required Intervention PROGRAMMER MODEL UNK N=1| IMPLANTABLE PULSE GNEREATOR MODEL UNK N=1| EXTENSION MODEL UNK N=2| LEAD MODEL UNK N=1