BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1515437 · Received October 16, 2009

    Report

    Report Number
    2182207-2009-07495
    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

    Additional Manufacturer Narrative · 1

    .

    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 DISORD. 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 SHOWED MILD COGNITIVE IMPAIRMENT. THE PATIENT'S COGNITIVE PERFORMANCE AT BASELINE WAS COMPLETELY WITHIN THE NORMATIVE RANGE; ONLY THE LOGICAL MEMORY TASK WAS FOUND TO RECORD AT LOWER SCORE. AT 36 MONTHS AFTER IMPLANT, THE PATIENT SHOWED MILD COGNITIVE IMPAIRMENT INDICATIVE OF FRONTAL DYSFUNCTION, BUT DID NOT MEET THE CRITERIA FOR DEMENTIA. MRI EXAMINATION CONFIRMED CORRECT POSITION OF THE ELECTRODE. SEE LITERATURE ARTICLE WITH MFR REPORT # 2182207200907493.

    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 67 YR Disability EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK