BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1069609 · Received July 3, 2008

    Report

    Report Number
    2182207-2008-03758
    Event Type
    Injury
    Date Received
    July 3, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ANHEIM M, BATIR A, FRAIX V, ET AL. IMPROVEMENT IN PARKINSON DISEASE BY SUBTHALAMIC NUCLEUS STIMULATION BASED ON ELECTRODE PLACEMENT: EFFECTS OF REIMPLANTATION. ARCH NEUROL. 2008;65 (5): 612-616. THE OBJECTIVE IS TO EVALUATE WHETHER REIMPLANTATION OF ELECTRODE IN THE STN CAN PRODUCE IMPROVEMENT IN PTS WITH POOR RESULTS FROM SURGERY AND WITH SUSPECTED ELECTRODE MISPLACEMENT BASED ON IMAGING FINDINGS. REPORTABLE EVENT: EXCEPT FOR 1 PT, ALL PTS DEMONSTRATED IMPROVEMENTS FOR THE PRIMARY AND SECONDARY OUTCOMES. THE LEFT-SIDED THERAPEUTIC CONTACT OF THE PT WHO SHOWED NO IMPROVEMENT FOLLOWING REIMPLANTATION REMAINED 4.2MM FROM THE TET. SEE MFG REPORT 2182207200803751.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization PROGRAMMER MODEL UNK N=1| LEAD MODEL UNK N=2| EXTENSTION MODEL UNK N=2