BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2098701 · Received May 18, 2011

    Report

    Report Number
    3007566237-2011-03630
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 6, 2008
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    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 ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: NUNTA-AREE S, SITTHINAMSUWAN B, BOONYAPISIT K, PISARNPONG 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)(6) CLINICAL OUTCOMES, CHANGES OF MEDICATION AND COMPLICATIONS FOLLOWING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN PATIENTS WHO PRESENTED WITH ADVANCED PARKINSON'S DISEASE IN (B)(6) TO (B)(6) SINCE 2004. TWENTY-SEVEN PATIENTS WITH (B)(6) F/U AND COMPLETE DATA WERE ENROLLED FOR RETROSPECTIVE EVAL OF UNIFIED PARKINSON'S DISEASE RATING SCALE, AND 62 PATIENTS WERE ENROLLED FOR STUDY OF SURGICAL COMPLICATIONS. REPORTABLE EVENTS: ONE PT EXPERIENCED WOUND INFECTION. ONE PT EXPERIENCED A STIMULATION INDUCED HEMIBALLISM. ONE PT EXPERIENCED AN ASYMPTOMATIC INTRACEREBRAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK