BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOLETRA OR ITREL II

    MDR report key: 951546 · Received November 15, 2007

    Report

    Report Number
    2182207-2007-03850
    Event Type
    Other
    Date Received
    November 15, 2007
    Report Date
    October 14, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE LIMITATIONS OF THE DATA, THE REPORTABLE EVENTS ARE BEING SUBMITTED BY COMPLICATION TYPE. THE EXACT RELATIONSHIP BETWEEN EACH PT, THE DEVICES USED AND THE COMPLICATIONS EXPERIENCED WAS NOT PROVIDED. IT IS POSSIBLE THAT EACH PT MAY HAVE EXPERIENCED MORE THAN ONE COMPLICATION.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GILL, ET AL. "DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE: THE VANDERBILT UNIVERSITY MEDICAL CENTER EXPERIENCE 1998-2004" TENNESSEE MEDICINE; 2007; 100: P 45-47. THE ARTICLE PRESENTS STUDY RESULTS DESCRIBING THE OUTCOMES AND ADVERSE EVENT RATES FROM 72 PTS FOLLOWED FOR AN AVERAGE OF 22 MONTHS. THE PTS, ALL WITH ADVANCED PARKINSONS DISEASE, WERE BEING TREATED WITH UNILATERAL OR BILATERAL DEEP BRAIN STIMULATION OF THE STN. A NUMBER OF NEUROSTIMULATION PT COMPLICATIONS WERE REPORTED. REPORTABLE EVENT(S): FOUR PTS EXPERIENCED AN UNSPECIFIED ADVERSE EVENT RELATED TO THE DBS THERAPY. TREATMENT AND OUTCOME INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA OR ITREL II MHY MEDTRONIC NEUROMODULATION 7424 OR 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other SPECIFIC IF THE PTS SYSTEM WAS UNILATERAL| OR BILATERAL| FOR EACH PT: LEAD EXTENSIONS| SOLETRA OR ITREL II IPG. THE ARTICLE DID NOT