BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2481623 · Received March 7, 2012

    Report

    Report Number
    3007566237-2012-00486
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    February 21, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: POURFAR, MICHAEL H., CHRIS C. TANG, ALON Y. MOGILNER, VIJAY DHAWAN, AND DAVID EIDELBERG. "USING IMAGING TO IDENTIFY PSYCHOGENIC PARKINSONISM BEFORE DEEP BRAIN STIMULATION SURGERY." JOURNAL OF NEUROSURGERY 116.1 (2011): 114-18. PRINT. SUMMARY: THE AUTHORS REPORT ON 2 PATIENTS WITH PROBABLE PSYCHOGENIC PARKINSONISM WHO PRESENTED FOR DBS SURGERY. THEY FOUND THAT BOTH PATIENTS HAD NORMAL CAUDATE AND PUTAMEN [(18)F]-FLUORODOPA UPTAKE ON PET IMAGING, ALONG WITH NORMAL EXPRESSION OF SPECIFIC DISEASE-RELATED METABOLIC NETWORKS FOR PD AND MULTIPLE SYSTEM ATROPHY, A COMMON FORM OF ATYPICAL NEURODEGENERATIVE PARKINSONISM. THE CLINICAL AND PET FINDINGS IN THESE PATIENTS HIGHLIGHT THE ROLE OF FUNCTIONAL IMAGING IN ASSISTING CLINICAL DECISION MAKING WHEN THE DIAGNOSIS IS UNCERTAIN. REPORTED EVENT: A (B)(6) WOMAN REPORTED HAVING DEVELOPED A SLIGHT TREMOR OF THE LEFT ARM ALONG WITH LEFT STIFFNESS, MUSCLE SPASMS, SLOWNESS, FATIGUE, AND NIGHT SWEATS 5 YEARS EARLIER. THIS DIAGNOSIS NOTWITHSTANDING, UNILATERAL SUBTHALAMIC NUCLEUS DBS SURGERY WAS PERFORMED DUE TO THE REPORTED LEVODOPA RESPONSE; THE STIMULATOR WAS REMOVED WITHIN 1 MONTH, HOWEVER, DUE TO AN INTRACRANIAL ABSCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNK SERIAL# UNK