BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2181247 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05677
    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 Location
    CA
    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 ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: MORO E, SCHWALB JM, PIBOOLNURAK P, ET AL. UNILATERAL SUBDURAL MOTOR CORTEX STIMULATION IMPROVES ESSENTIAL TREMOR BUT NO PARKINSON'S DISEASE. BRAIN. JUL 2011;134(PT 7):2096-2105. SUMMARY: THIS STUDY LOOKED AT THE EFFICACY AND SAFETY OF UNILATERAL SUBDURAL MOTOR CORTEX STIMULATION IN SIX PATIENTS WITH ESSENTIAL TREMOR (ET) AND FIVE PATIENTS WITH ADVANCED PARKINSON'S DISEASE (PD) BETWEEN (B)(6) 2004 AND (B)(6) 2006. PATIENTS WERE ASSESSED DURING ACUTE, INTERMEDIATE AND CHRONIC (B)(6) STIMULATION. PRIMARY OUTCOME MEASURES IN PT WITH ET WERE CHANGES IN TREMOR SCORES (B)(6) AND IN PATIENTS WITH PD CHANGES IN (B)(6) MOTOR 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 EVENTS: ONE PT WITH PD EXPERIENCED A GENERALIZED TONIC-CLONIC SEIZURE IN THE IMMEDIATE POST-OPERATIVE PERIOD. THE PT ALSO SHOWED A SLIGHT WORSENING OF TREMOR AND RIGIDITY IN THE OFF MEDICATION/ON STIMULATION AND OFF MEDICATION/OFF STIMULATION CONDITIONS AT THE THREE MONTH F/U. AT THE ONE-YEAR F/U, THERE WAS A WORSENING OF THE TOTAL MOTOR UPDRS SCORES IN BOTH: THE OFF MEDICATION/ON STIMULATION CONDITION COMPARED WITH THE OFF MEDICATION CONDITION BEFORE SURGERY AND THE ON MEDICATION/ON STIMULATION CONDITION COMPARED WITH THE ON MEDICATION CONDITION BEFORE SURGERY. THE TOTAL (B)(6) SCORE ALSO WORSENED BOTH IN THE ON AND OFF MEDICATION CONDITIONS AT THE ONE YEAR F/U. THE LEVODOPA EQUIVALENT DAILY DOSE WAS SLIGHTLY INCREASED AT 1 YEAR AS COMPARED TO 3 MONTHS AND BEFORE SURGERY. THREE PATIENTS WITH PD EXPERIENCED SIMPLE PARTIAL MOTOR SEIZURES DURING THE ACUTE TESTING PERIOD AND WERE STARTED ON PHENYTOIN OR CARBAMAZEPINE. THE MEDICATIONS WERE DISCONTINUED AT THE END OF THE ACUTE STIMULATION PERIOD WITH NO SUBSEQUENT RECURRENCE OF SEIZURES. THE PATIENTS ALSO SHOWED A SLIGHT WORSENING OF TREMOR AND RIGIDITY IN THE OFF MEDICATION/ON STIMULATION AND OFF MEDICATION/OFF STIMULATION CONDITIONS AT THE THREE MONTH F/U. AT THE ONE-YEAR F/U, THERE WAS A WORSENING OF THE TOTAL MOTOR UPDRS SCORES IN BOTH: THE OFF MEDICATION/ON STIMULATION CONDITION COMPARED WITH THE OFF MEDICATION CONDITION BEFORE SURGERY AND THE ON MEDICATION/ON STIMULATION CONDITION COMPARED WITH THE ON MEDICATION CONDITION BEFORE SURGERY. THE TOTAL (B)(6) SCORE ALSO WORSENED BOTH IN THE ON AND OFF MEDICATION CONDITIONS AT THE ONE YEAR F/U. THE LEVODOPA EQUIVALENT DAILY DOSE WAS SLIGHTLY INCREASED AT 1 YEAR AS COMPARED TO 3 MONTHS AND BEFORE SURGERY. SEE MFR REPORT #3007566237201105668 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 73 YR Other EXPLANTED:| LEAD: MODEL 3587A, LOT# UNK