BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1226575 · Received November 11, 2008

    Report

    Report Number
    2182207-2008-07305
    Event Type
    Injury
    Date Received
    November 11, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: HEO JH, LEE KM, PAEK SH, ET AL. THE EFFECTS OF BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN DBS) ON COGNITION IN PARKINSON DISEASE. J NEUROL SCI. 2008; 273 (1-2): 19-24. THE EFFECTS OF SUBTHALAMIC NUCLEUS (STN) STIMULATION ON COGNITION AND MOOD HAVE NOT BEEN WELL ESTABLISHED. THE AUTHORS ESTIMATED COGNITIVE AND MOOD EFFECTS OF BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN DBS) IN PATIENTS WITH PARKINSON'S DISEASE (PD) AT 6 MONTHS AND 1 YEAR POSTOPERATIVELY. FORTY-SIX PATIENTS WERE RECRUITED, AND FOLLOWED FOR 1 YEAR AFTER SURGERY. OF THE BASELINE CHARACTERISTICS, AGE AT ONSET, NUMBER OF YEARS IN FULL-TIME EDUCATION, AND L-DOPA EQUIVALENT DOSAGE WERE FOUND TO BE CORRELATED WITH A POSTOPERATIVE DECLINE IN NEUROPSYCHOLOGICAL TEST RESULTS. IN CONCLUSION, BILATERAL STN DBS IN PARKINSON'S DISEASE DID NOT LEAD TO A SIGNIFICANT GLOBAL DETERIORATION IN COGNITIVE FUNCTION. HOWEVER, OUR FINDINGS SUGGEST THAT IT HAS MINOR DETRIMENTAL LONG-TERM IMPACTS ON MEMORY AND FRONTAL LOBE FUNCTION. REPORTABLE EVENT: OF THE TESTS PERFORMED, THE VERBAL MEMORY TEST, THE STROOP TEST, AND THE WORD FLUENCY TEST SHOWED STATISTICALLY SIGNIFICANT CHANGES. THE VERBAL MEMORY TEST USING THE REY-KIM MEMORY BATTERY SHOWED A DECLINE IN DELAYED RECALL AND RECOGNITION AT 6 MONTHS AND 1 YEAR POSTOPERATIVELY, WHEREAS NONVERBAL MEMORY SHOWED NO MEANINGFUL CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PROGRAMMER MODEL 8840 N=1| LEAD MODEL 3389 N=2| EXTENSION MODEL UNK N=2