BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1161219 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05757
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: FARRIS SM, GIROUX ML. GAIT CHANGES AFTER DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE IN A PT WITH CERVICAL MYELOPATHY. NEUROREHABILITATION. 2008;23(3):263-265. WE PRESENT A MALE PT WITH SIGNIFICANT GAIT PROBLEMS DUE TO PARKINSON'S DISEASE WHO UNDERWENT STN DBS. GAIT WORSENED AFTER SURGERY DESPITE SIGNIFICANT IMPROVEMENTS IN PARKINSONIAN SIGNS, DUE TO UNDERLYING SPASTICITY PREVIOUSLY OVERSHADOWED BY HIS PARKINSONIAN MOTOR SYMPTOMS. THIS CASE ILLUSTRATES AN EMERGENCE OF DYSFUNCTION IN GAIT IN A PT WITH OTHERWISE IMPROVED FUNCTION AND REINFORCES THE NEED FOR AN INTERDISCIPLINARY APPROACH TO THE CARE OF THESE PTS. REPORTABLE EVENT: ONE MONTH AFTER IMPLANT THE PT HAD MODERATE TO SEVERE BRADYKINESIA, REST TREMOR AND RIGIDITY, POSTURAL INSTABILITY AND GAIT WORSENING WITH FALLS. EIGHT MONTHS LATER AFTER 6 MONTHS OF EXTENSIVE PHYSICAL THERAPY HIS GAIT AND BALANCE SIGNIFICANTLY IMPROVED; HE WAS ABLE TO WALK WITHOUT A AMBULATORY AID.

    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 Other LEAD MODEL UNK N=2| PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2