BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2143015 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04689
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 13, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED. A COPY OF THIS ARTICLE CAN BE ACCESSED AT WWW.INTERSCIENCE.WILEY.COM.

    Description of Event or Problem · 1

    LITERATURE: LAI SC, JUNG SM, GRATTAN-SMITH P, ET AL. NEURONAL INTRANUCLEAR INCLUSION DISEASE: TWO CASES OF DOPA-RESPONSIVE JUVENILE PARKINSONISM WITH DRUG-INDUCED DYSKINESIA. MOV DISORD. JUL 15 2010;25(9):1274-1279. SUMMARY: THIS ARTICLE DESCRIBED TWO CHILDREN WITH NEURONAL INTRANUCLEAR INCLUSION DISEASE (NIID) WHO PRESENTED WITH DOPA-RESPONSIVE JUVENILE PARKINSONISM, AND WHO HAD INITIAL GOOD LEVODOPA RESPONSE THAT WAS COMPLICATED BY DISABLING DOPA-INDUCED DYSKINESIA. BOTH PATIENTS DIED WITHIN 10 YEARS OF SYMPTOM ONSET. THE ARTICLE DISCUSSED DIFFERENTIAL DIAGNOSIS OF CLINICAL SYMPTOMS AND NEUROPATHOLOGICAL FINDS. EVENT: ONE FEMALE WHO UNDERWENT SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (DBS) EXPERIENCED A RETURN OF SYMPTOMS 6 MONTHS POST SURGERY AFTER INITIAL IMPROVEMENT OF TREMOR AND BRADYKINESIA, AND DEPRESSION AND LABILE EMOTION ONE YEAR AFTER SURGERY. SUBSEQUENTLY, THE PATIENT EXPERIENCED RECURRENT INFECTIONS AND DIED DUE TO ASPIRATION PNEUMONIA APPROXIMATELY TWO YEARS AFTER SURGERY. THE AUTHORS INDICATE THAT THE PATIENT'S WIDESPREAD PATHOLOGY PROBABLY ACCOUNTED FOR THE LACK OF SUSTAINED RESPONSE TO DBS. THE PATIENT'S MOTOR SYMPTOMS PRIOR TO SURGERY HAD PROGRESSED RAPIDLY AND HER COGNITIVE FUNCTION HAD DECLINED. THE PATIENT HAD DEMONSTRATED SEVERE GAIT ATAXIA, DYSARTHRIA, DYSPHAGIA, SACCADIC PURSUIT AND NYSTAGMUS, BLEPHAROSPASM AND FOCAL DYSTONIA IN DISTAL LIMBS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other IMPLANTED:| LEAD: MODEL LEADN, LOT# UNK| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK