BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1002335 · Received February 22, 2008

    Report

    Report Number
    2182207-2008-00861
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ARLE ET AL. "MOTOR CORTEX STIMULATION FOR PAIN AND MOVEMENT DISORDERS." NEUROTHERAPEUTICS 2008; 5(1): 37-49. THE STUDY INVOLVES 15 PTS (8 PAIN AND MOVEMENT DISORDERS, 4 PD, 2 ET AND 1 CORTICO-BASAL DEGENERATION), USING MOTOR CORTEX STIMULATION. THE PT CASES WERE DETAILED ALONG WITH A GENERAL REVIEW AND RESEARCH OF LITERATURE RELATIVE TO MODELING AND UNDERSTANDING THE UNDERLYING MECHANISMS OF MCS. REPORTABLE EVENT: AT 18 MONTH FOLLOW-UP IN 1 PAIN PT, A SEIZURE WAS GENERATED WHILE THE STIMULATOR VOLTAGE WAS BEING INCREASED. THE VOLTAGE HAS SINCE BEEN KEPT LOWER WITH NO FURTHER SEIZURE ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization IMPLANTABLE STIMULATOR MODEL UNK| IMPLANTABLE EXTENSIONS MODEL UNK (2)| PROGRAMMER MODEL UNK| IMPLANTABLE LEAD MODEL UNK (1)