BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2180989 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05673
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    February 23, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO HAS BEEN REQUESTED. (B)(6).

    Description of Event or Problem · 1

    LITERATURE: MORO E, SCHWALB JM, PIBOOLNURAK P, ET AL. UNILATERAL SUBDURAL MOTOR CORTEX STIMULATION IMPROVES ESSENTIAL TREMOR BUT NOT PARKINSON'S DISEASE. BRAIN. JUL 2011;134(PT7): 2096-2105. SUMMARY: THIS STUDY LOOKED AT THE EFFICACY AND SAFETY OF UNILATERAL SUBDURAL MOTOR CORTEX STIMULATION IN SIX PTS WITH ESSENTIAL TREMOR (ET) AND FIVE PTS WITH ADVANCED PARKINSON'S DISEASE (PD) BETWEEN (B)(6) 2004 AND (B)(6) 2006. PTS WERE ASSESSED DURING ACUTE, INTERMEDIATE AND CHRONIC (3 MONTHS DOUBLE-BLIND AND 1 YEAR OPEN) STIMULATION. PRIMARY OUTCOME MEASURES IN PT WITH ET WERE CHANGES IN TREMOR SCORES AT 3 MONTHS AND IN PTS WITH PD CHANGES IN (B)(6) SCORES AT 3 MONTHS IN OFF MEDICATION/ON STIMULATION VERSUS OFF MEDICATION/OFF STIMULATION AND ON MEDICATION/OFF STIMULATION VERSUS ON MEDICATION/ON STIMULATION CONDITIONS. REPORTABLE EVENT: A (B)(6) FEMALE PT WITH ET WHO WAS TAKING PRIMIDONE FOR TREMOR EXPERIENCED ONE OR MORE SIMPLE PARTIAL MOTOR SEIZURES DURING THE ACUTE TESTING PERIOD. SEE MFR REPORT #3007566237-2011-05668 FOR A COPY OF THE LITERATURE ARTICLE.

    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 65 YR Other EXPLANTED:| LEAD: MODEL 3587A, LOT# UNKNOWN| IMPLANTED: