BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATION

    MDR report key: 2093954 · Received May 16, 2011

    Report

    Report Number
    3007566237-2011-03552
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    October 23, 2010
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: ANTONINI A, ISAIAS IU, RODOLFI G, ET AL. A 5-YEAR PROSPECTIVE ASSESSMENT OF ADVANCED PARKINSON DISEASE PATIENTS TREATED WITH SUBCUTANEOUS APOMORPHINE INFUSION OR DEEP BRAIN STIMULATION. J NEUROL. APRIL 2011;258(4):579-585. SUMMARY: THE AUTHORS CONDUCTED A PROSPECTIVE COMPARATIVE LONG-TERM STUDY ON THE EFFECT OF DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) AND CONTINUOUS SUBCUTANEOUS INFUSION OF APOMORPHINE (CSAI) IN PATIENTS WITH ADVANCED PARKINSON DISEASE (PD). TWENTY-FIVE PATIENTS WERE TREATED WITH EITHER STN-DBS (N = 13) OR CSAI (N = 12); TWELVE SUBJECTS REACHED THE (B)(6) FOLLOW-UP WITH STN-DBS VERSUS TWO IN THE CSAI COHORT. REPORTABLE EVENT: ONE PATIENT EXPERIENCED A (B)(6) ADVERSE EVENT, THEIR LEADS BECAME INFECTED. THE INFECTED DEVICE COMPONENTS WERE REMOVED AND RE-IMPLANTED FOLLOWING AN APPROPRIATE COURSE OF INTRAVENOUS ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD UNK