BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1564647 · Received December 18, 2009

    Report

    Report Number
    3007566237-2009-09481
    Event Type
    Death
    Date Received
    December 18, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 8, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: DENHEYER M, KISS ZH, HAFFENDEN AM. BEHAVIORAL EFFECTS OF SUBTHALAMIC DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE. NEUROPSYCHOLOGIA. 2009; 47(14):3203-9. SUMMARY: THIS ARTICLE PRESENTS A REVIEW OF 16 PTS WITH IDIOPATHIC PARKINSON'S DISEASE WHO UNDERWENT BILATERAL STN DBS BETWEEN 2002 AND 2006. POSTOPERATIVELY, THE PTS WERE ASSESSED WITH THE FRONTAL SYSTEMS BEHAVIOR SCALE (FRSBE) TO PROVIDE A QUANTITATIVE ASSESSMENT OF POST-OPERATIVE BEHAVIORAL FUNCTIONING. THE PRIMARY OBJECTIVE WAS TO EXPLORE THE UTILITY OF THE FRSBE IN CHARACTERIZING BEHAVIOR DISTURBANCE. SECONDLY, THE STUDY SOUGHT TO EXAMINE THE RELATIONSHIP BETWEEN FRSBE SCORES, MOOD, MOTOR FUNCTION, AND COGNITIVE MEASURES. FINALLY, THE STUDY SOUGHT TO DETERMINE THE RELATIONSHIP BETWEEN SELF- AND FAMILY REPORTS OF BEHAVIOR. REPORTABLE EVENT: THREE PTS WERE EXCLUDED FROM THE STUDY DUE TO DEATH UNRELATED TO THE IMPLANT SURGERY. NO CAUSE OF DEATH OR RELATIONSHIP OF THE PT'S DEATH TO THE DEEP BRAIN STIMULATION THERAPY WAS REPORTED.

    Devices

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

    Patients

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