BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 2446686 · Received February 10, 2012

    Report

    Report Number
    3007566237-2012-00292
    Event Type
    Death
    Date Received
    February 10, 2012
    Date of Event
    February 24, 2011
    Report Date
    January 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE EXACT DATES WERE NOT PROVIDED AND ARE AN ESTIMATE BASED ON THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: A. M. STRUTTA, R. SIMPSONB, J. JANKOVICA AND M. K. YORKA,C. CHANGES IN COGNITIVE-EMOTIONAL AND PHYSIOLOGICAL SYMPTOMS OF DEPRESSION FOLLOWING STN-DBS FOR THE TREATMENT OF PARKINSON'S DISEASE. EUROPEAN JOURNAL OF NEUROLOGY 2012, 19: 121-127. DOI:1 0.1111/J.1468-1331.2011.03447.X SUMMARY: BACKGROUND AND PURPOSE: SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) HAS BEEN SHOWN TO HAVE BENEFICIAL EFFECTS ON THE MOTOR FEATURES OF PARKINSON'S DISEASE (PD), BUT ITS IMPACT ON NON-MOTOR SYMPTOMS, MOST NOTABLY MOOD, HAS NOT BEEN FULLY EXPLORED. METHODS: IN THE FIRST STUDY TO INDEPENDENTLY COMPARE THE EMOTIONAL-COGNITIVE AND SOMATIC/PHYSIOLOGICAL SYMPTOMS OF DEPRESSION, WE EXAMINED MOOD DIFFERENCES IN 17 BILATERAL STN-DBS AND 22 MATCHED NON-SURGICAL PD PATIENTS AT BASELINE AND 6 MONTHS. RESULTS: THE STN-DBS GROUP REPORTED HIGHER LEVELS OF DEPRESSION AT BASELINE WITH SIGNIFICANT ENDORSEMENT OF PHYSICAL SYMPTOMATOLOGY. POSTOPERATIVELY, NO SIGNIFICANT BETWEEN-GROUP DIFFERENCES IN PHYSICAL SYMPTOMS OF DEPRESSION WERE FOUND. IN CONTRAST, A SIGNIFICANT GROUP BY TIME INTERACTION FOR COGNITIVE-EMOTIONAL SYMPTOMS OF DEPRESSION WAS FOUND, WITH THE STN-DBS GROUP REPORTING AN INCREASE IN PSYCHOLOGICAL SYMPTOMS OF DISTRESS. THE STN-DBS GROUP ALSO REPORTED AN INCREASE IN ANXIETY FOLLOWING SURGERY. THE SUICIDE RATE OF 5% FOUND IN O UR STUDY IS CONSISTENT WITH OTHER POSTOPERATIVE STUDIES IN PD. THE IMPACT OF CHANGES IN LEVODOPA AND PSYCHOTROPIC MEDICATION ARE ALSO EXPLORED. CONCLUSIONS: PRELIMINARY RESULTS SUGGEST THAT THE MOTOR IMPROVEMENT OFTEN OBSERVED IN PATIENTS WITH PD FOLLOWING BILATERAL STN-DBS MAY BE PARTIALLY OFFSET BY AN INCREASE IN AFFECTIVE-COGNITIVE SYMPTOMS OF DEPRESSION. THE MOTOR SYMPTOMS OF PARKINSON'S DISEASE (PD) ARE THE PREDOMINANT OUTCOME OF INVESTIGATION FOLLOWING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS). HOWEVER, RECENT STUDIES HAVE DESCRIBED THE POTENTIALLY NEGATIVE IMPACT OF STN-DBS ON NON-MOTOR SYMPTOMS, SUCH AS THE INFLUENCES OF POOR MOOD STATE AND COGNITION ON OVERALL QUALITY OF LIFE (QOL). A CONSENSUS REGARDING MOOD CHANGES FOLLOWING STN-DBS HAS NOT BEEN REACHED. SEVERAL STUDIES INVESTIGATING THE PSYCHIATRIC SYMPTOMS OF PATIENTS FOLLOWING STN-DBS. REPORTED EVENT: THE INCREASE IN TOTAL DEPRESSION SCORES FOR THE STN-DBS GROUP WAS A RESULT OF AN ELEVATION IN COGNITIVE-EMOTIONAL SYMPTOMS OF DEPRESSION, MOST NOTABLY A RISE IN REPORTED SADNESS, DISCOURAGEMENT, FAILURE, GUILT, SELF-DISAPPOINTMENT, SELFCRITICALNESS, AND LACK OF INTEREST. OVERALL THE INCIDENCE OF DEPRESSION INCREASED 12% FOR THE STN-DBS PATIENTS FOLLOWING SURGERY FOR A TOTAL INCIDENCE RATE OF 56% OF STN-DBS PATIENTS MEETING CRITERIA FOR AT LEAST MILD DEPRESSION. MOREOVER, THE STN-DBS PATIENTS REPORTED HIGHER LEVELS OF SITUATIONAL AND CHARACTEROLOGICAL ANXIETY AT THEIR 6-MONTH EVALUATION. OF THE ORIGINAL SAMPLE, TWO PATIENTS DID NOT RETURN FOR THEIR FOLLOW-UP BECAUSE OF A SIGNIFICANT INCREASE IN DEPRESSIVE SYMPTOMATOLOGY AS REPORTED BY THEIR FAMILY, AND ONE ADDITIONAL PATIENT RETURNED FOR HIS APPOINTMENT, BUT REFUSED TO COMPLETE THE FULL EVALUATION BECAUSE OF HIS POOR MOOD STATE. ONE PATIENT COMMITTED SUICIDE THREE MONTHS POST-SURGERY. THE SUICIDE WAS ASSOCIATED WITH A MARKED DECREASE IN MOOD DURING THE POST-OPERATIVE PERIOD WITHOUT ANY SPECIFIC TRIGGERS OR STRESSORS. FURTHER INFORMATION IS BEING REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R