BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1515436 · Received October 16, 2009

    Report

    Report Number
    2182207-2009-07493
    Event Type
    Injury
    Date Received
    October 16, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 6, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: ZANGAGLIA R, PACCHETTI C, PASOTTI C, ET AL. DEEP BRAIN STIMULATION AND COGNITIVE FUNCTIONS IN PARKINSON'S DISEASE: A THREE-YEAR CONTROLLED STUDY. MOV DISCORD. 2009; 24(11): 1621-8. SUMMARY: THIS ARTICLE PRESENTS A PROSPECTIVE, NATURALISTIC CONTROLLED 3-YEAR FOLLOW-UP STUDY OF 65 CONSECUTIVE PATIENTS WITH PARKINSON'S DISEASE (32 UNDERWENT STN-DBS IMPLANT, 33 WERE ELIGIBLE, BUT CHOSE OTHER THERAPEUTIC PROCEDURES) ENROLLED FROM 2002 TO 2003. THE AIM OF THE STUDY WAS TO ASSESS THE COGNITIVE AND BEHAVIORAL EFFECTS OF DBS OF THE STN IN ADVANCE PARKINSON'S DISEASE. MOTOR AND NEUROPSYCHOLOGICAL FUNCTIONS WERE ASSESSED IN ALL THE SUBJECTS AT BASELINE AND 36 MONTHS. DBS PATIENTS WERE ALSO EVALUATED AT 1, 6, 12, AND 24 MONTHS AFTER SURGERY. REPORTABLE EVENT: THREE YEARS AFTER IMPLANT ONE PATIENT DEVELOPED DSM-IV DEMENTIA. IT WAS NOTED THE PT'S NEROPSYCHOLOGICAL EVALUATION AND MMSE SCORE WERE AT THE LOWER LIMITS OF THE NORMATIVE RANGE AT BASELINE. AT 36 MOS, SHE SHOWED A GLOBAL DECLINE IN ALL THE COGNITIVE FUNCTIONS EVAL. THERE WAS ALSO NOTED TO BE NO EVIDENCE OF SIGNIFICANT IMPROVEMENT AFTER DBS IMPLANT. MRI EXAMINATION CONFIRMED CORRECT POSITION OF THE ELECTRODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability LEAD: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED: