BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1190322 · Received October 6, 2008

    Report

    Report Number
    2182207-2008-06356
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    September 8, 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: LAMBRECQ V, KIM E, MEISSNER W, GUEHL D, TISON F. (DEEP-BRAIN STIMULATION OF THE INTERNAL PALLIDUM IN MULTIPLE SYSTEM STROPHY). REV NEUROL (PARIS). 2008; 164 (4): 398-402. WE DESCRIBE THE OUTCOME OF BILATERAL DBS OF THE INTERNAL PALLIDUM IN A WOMAN SUFFERING FROM MULTIPLE-SYSTEM ATROPHY, MSA, THAT INITIALLY RESEMBLED PARKINSON'S DISEASE WITH PROMINENT LEVODOPA-INDUCED DYSKINESIAS. DBS OF THE LEFT INTERNAL PALLIDUM WAS PERFORMED IN 1998 AFTER A TEN-YEAR CLINICAL COURSE AND IMPROVED DYSKINESIAS. SIX MONTHS LATER, THE RIGHT SIDE WAS IMPLANTED. A FEW MONTHS AFTER THE SECOND SURGERY, THE PATIENT PROGRESSIVELY DEVELOPED SIGNS OF CEREBELLAR AND DYSAUTONOMIC IMPAIRMENT AND MSA WAS DIAGNOSED. OUR OBSERVATION CONFIRMS THE INEFFECTIVENESS OF DBS OF THE INTERNAL PALLIDUM IN MSA AND EVEN SUGGESTS A HARMFUL EFFECT. DBS REMAINS CONTRA-INDICATED IN ATYPICAL PARKINSONISM. REPORTABLE EVENT: WITHIN TWO MONTHS OF THIS SECOND PROCEDURE, THE CLINICAL COURSE DETERIORATED WITH EXACERBATED AKINESIA. SUBSEQUENTLY, CEREBELLAR ATAXIA, DYSAUTONOMIA WITH SEVERE VESICOSPHINCTER DISORDER (INCONTINENCE AND URINE RETENTION ASSOCIATED WITH VESICOSPHINCTER DYSSYNERGY CONFIRMED BY URODYNAMIC EVALUATION) AND ORTHOSTATIC HYPOTENSION, PYRAMIDAL SYNDROME AND CERVICOFACIAL DYSTONIA (BLEPHAROSPASM, ANTECOLLIS) GRADUALLY DEVELOPED. THE PATIENT THUS SATISFIED THE CONSENSUS CRITERIA FOR THE DIAGNOSIS OF TYPE P "PROBABLE" MSA. GIVEN THE LOSS OF EFFICACY OF DBS AND THE EXACERBATION OF THE PATIENT'S CONDITION DBS WAS STOPPED IN 2003.

    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 46 YR Required Intervention EXTENSION MODEL UNK N=2| LEAD MODEL 3387 N=2| PROGRAMMER MODEL UNK N=1