BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2297782 · Received October 7, 2011

    Report

    Report Number
    3007566237-2011-08530
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    May 6, 2008
    Report Date
    September 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: NUNTA-AREE S, SITTHINAMSUWAN B, BOONYAPISIT K, PISAMPOMG A, SW2-YEAR OUTCOMES OF SUBTHALAMIC DEEP BRAIN STIMULATION FOR IDIOPATHIC PARKINSON'S DISEASE. J MED ASSOC THAI. MAY 2010;93(5):529-540. SUMMARY: THIS ARTICLE STUDIED (B)(4) CLINICAL OUTCOMES, CHANGES OF MEDICATION AND COMPLICATIONS FOLLOWING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN PTS WHO PRESENTED WITH ADVANCED PARKINSON'S DISEASE IN (B)(6) TO ONE CLINICAL GROUP SINCE 2004. TWENTY-SEVEN PTS WITH (B)(6) F/U AND COMPLETE DATA WERE ENROLLED FOR RETROSPECTIVE EVAL OF UNIFIED PARKINSON'S DISEASE RATING SCALE, AND 62 PTS WERE ENROLLED FOR STUDY OF SURGICAL COMPLICATIONS. EVENT: THE AUTHORS REPORTED THAT ONE LEAD WAS "MALPOSITIONED." ADDITIONAL INFO WAS RECEIVED THAT INDICATED A LEAD REVISION WAS PERFORMED AND NO COMPONENTS WERE EXPLANTED. FINAL PT OUTCOME INDICATED THAT THE PT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention (B)(4)| LEAD: MODEL 3389-40 LED KIT, (B)(4)