BEUDAMED
    FDA Adverse Event Summary report: N

    DEEP BRAIN STIMULATION DEVICES

    MDR report key: 921663 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03052
    Date Received
    September 21, 2007
    Report Date
    September 30, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GORGULHO A. ET AL. "INCIDENCE OF HEMORRHAGE ASSOCIATED WITH ELECTROPHYSIOLOGICAL STUDIES PERFORMED USING MACROELECTRODES AND MICROELECTRODES IN FUNCTIONAL NEUROSURGERY." J. NEUROSURG. 2005 MAY: 102(5): P888-896. THE ARTICLE ANALYZE THE INCIDENCE OF INTRACRANIAL IN PATIENTS WHO UNDERWENT PROCEDURES GUIDED BY MICROELECTRODE RECORDING (MER) RATHER THAN BY MICROELECTRODE STIMULATION ALONE. REPORTABLE EVENTS: 3389 LEAD (N=1) - FEMALE PT IMPLANTED FOR PARKINSONS EXPERIENCED MILD HEMIPARESIS FOLLOWING THE MICROELECTRODE RECORDING (MER) AND DBS LEAD PLACEMENT PROCEDURES. MRI IDENTIFIED AN INTRACRANIAL HEMORRHAGE SURROUNDING THE TRACT OF THE ELECTRODE AND FRONTAL REGION. THREE PASSES OF THE MICROELECTRODES RECORDING (MER) WAS REQUIRED PRIOR TO DBS LEAD PLACEMENT. NO SURGERY WAS REQUIRED DUE TO THE SIZE OF THE HEMORRHAGE. THE 3389 LEAD (N=1) - FEMALE PATIENT IMPLANTED FOR PARKINSONS EXPERIENCED SUBARACHNOID HEMORRHAGE AND EXPRESSIVE DYSPHASIA. TWO PASSES OF THE MICROELECTRODE RECORDING (MER) WAS REQUIRED PRIOR TO DBS LEAD PLACEMENT. CT/MRI IDENTIFIED AN INTRACRANIAL HEMORRHAGE SURROUNDING THE TRACK OF THE ELECTRODE. NO SEQUELA. THE 3387 LEAD (N=1) - FEMALE PATIENT IMPLANTED FOR POSTTRAUMATIC TREMOR EXPERIENCED ASYMPTOMATIC HEMORRHAGE. MRI IDENTIFIED AN INTRACRANIAL HEMORRHAGE SURROUNDING THE TRACK OF THE ELECTRODE. ONE PASS OF THE MACROELECTRODE RECORDING WAS REQUIRED PRIOR TO DBS LEAD PLACEMENT. NO SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION DEVICES MHY MEDTRONIC NEUROMODULATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR