BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1617790 · Received February 18, 2010

    Report

    Report Number
    3007566237-2010-01202
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) APPETITE CHANGES.

    Description of Event or Problem · 1

    LITERATURE: PORAT O, COHEN OS, SCHWARTZ R, HASSIN-BAER S. ASSOCIATION OF PREOPERATIVE SYMPTOM PROFILE WITH PSYCHIATRIC SYMPTOMS FOLLOWING SUBTHALAMIC NUCLEUS STIMULATION IN PTS WITH PARKINSON'S DISEASE. J NEUROPSYCHIATRY CLIN NEUROSCI.2009; 21(4): 398-405. SUMMARY: THIS ARTICLE PRESENTS A RETROSPECTIVE STUDY OF 22 PTS WITH PARKINSON'S DISEASE WHO WERE EVALUATED FOR PRE- AND POSTOPERATIVE SYMPTOMS USING A NEUROBEHAVIORAL BATTERY TO EVALUATE THE CHANGE IN THE NEUROBEHAVIORAL AND NEUROPSYCHIATRIC SYMPTOMS FOLLOWING STN-DBS AND TO IDENTIFY POSSIBLE RISK FACTORS FOR THEIR OCCURRENCE. MEDICAL CHARTS WERE REVIEWED FOR DEMOGRAPHIC DATA, CLINICAL ASPECTS, PHARMACOTHERAPY, AND STIMULATION PATTERNS. PTS AND THEIR CAREGIVERS WERE INTERVIEWED BY A NEUROLOGIST OR PSYCHOLOGIST IN PERSON AND BY TELEPHONE USING CLINICIAN AND PT RATING SCALES. THEY WERE ASKED TO RATE SEVERAL ASPECTS OF BEHAVIOR DURING THE THREE MONTHS BEFORE THE ASSESSMENT, AND RETROSPECTIVELY FOR THE THREE MONTHS PRECEDING THE DBS OPERATION. NINETEEN PTS WERE IMPLANTED BILATERALLY, ONE UNILATERALLY IN THE LEFT HEMISPHERE, AND TWO UNILATERALLY IN THE RIGHT HEMISPHERE. REPORTABLE EVENT: FOUR NEW CASES OF HALLUCINATIONS AND APPETITE CHANGES FOLLOWING DBS IMPLANT WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXTENSION: MODEL UNKNOWN, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNKNOWN, LOT# UNKNOWN| IMPLANTED:| EXTENSION: MODEL UNKNOWN, LOT# UNKNOWN| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNKNOWN, LOT# UNKNOWN| IMPLANTED: