BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1163605 · Received September 17, 2008

    Report

    Report Number
    2182207-2008-05845
    Event Type
    Injury
    Date Received
    September 17, 2008
    Report Date
    August 20, 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

    LITERATURE: BIOLSI B, CIF L, FERTIT HE, ROBLES SG, COUBES P. LONG-TERM FOLLOW-UP OF HUNTINGTON DISEASE TREATED BY BILATERAL DEEP BRAIN STIMULATION OF THE INTERNAL GLOBUS PALLIDUS. J NEUROSURG. 2008;109(1):130-132. DEEP BRAIN STIMULATION IS NOW ACCEPTED AS A SAFE AND EFFICIENT TREATMENT FOR MOVEMENT DISORDERS INCLUDING SELECTED TYPES OF DYSTONIA AND DYSKINESIA. VERY LITTLE, HOWEVER, IS KNOWN ABOUT ITS EFFECT ON OTHER MOVEMENT DISORDERS, PARTICULARLY FOR "CHOREIC" MOVEMENTS. HUNTINGTON DISEASE IS A FATAL AUTOSOMAL-DOMINANT NEURODEGENERATIVE DISORDER CHARACTERIZED BY MOVEMENT DISORDERS, PROGRESSIVE COGNITIVE IMPAIRMENT, AND PSYCHIATRIC SYMPTOMS. BILATERAL CHRONIC STIMULATION OF THE INTERNAL GLOBUS PALLIDUS WAS PERFORMED TO CONTROL CHOREIC MOVEMENTS IN A MAN WITH A 10-YEAR HISTORY OF HUNTINGTON DISEASE. CHRONIC DEEP BRAIN STIMULATION RESULTED IN REMARKABLE IMPROVEMENT OF CHOREIC MOVEMENTS. POSTOPERATIVE IMPROVEMENT WAS SUSTAINED AFTER 4 YEARS OF FOLLOW-UP WITH A MARKED IMPROVEMENT IN DAILY QUALITY OF LIFE. REPORTABLE EVENT: BRADYKINESIA IN THE LOWER EXTREMITIES WAS VISIBLE 2-3 WEEKS AFTER DBS, WHICH IMPROVED FOLLOWING TREATMENT WITH LEVODOPA (187.5 MG). FOUR YEARS AFTER SURGERY THE IMPROVEMENT OF CHOREA REMAINED STABLE. WE OBSERVED A CLEAR IMPROVEMENT IN MOTOR CONTROL WHEN COMPARING STIMULATION-ON AND -OFF CONDITIONS AT 4 YEARS. NEUROPSYCHOLOGICAL ASSESSMENT AGAIN FOUND A MODERATE SUBCORTICAL COGNITIVE DYSFUNCTION WITH NO EVOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other PROGRAMMER MODEL UNK N=1| LEAD MODEL UNK N=2| SOLETRA MODEL 7426 N=1| EXTENSION MODEL UNK N=2