BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2246503 · Received September 6, 2011

    Report

    Report Number
    3007566237-2011-07438
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: ACKERMANS L, DUTS A, VAN DER LINDEN C, E AL. DOUBLE-BLIND CLINICAL TRIAL OF THALAMIC STIMULATION IN PTS WITH TOURETTE SYNDROME, BRAIN, MAR 2011;134(P13):832-844. DOI:(B)(4). SUMMARY: THE AUTHORS USED DEEP BRAIN STIMULATION OF THE THALAMUS AS A THERAPEUTIC OPTION IN PTS WITH TOURETTE SYNDROME WHO ARE REFRACTORY TO PHARMACOLOGICAL AND PSYCHOTHERAPEUTIC TREATMENT. PTS WERE INVITED TO TAKE PART IN A DOUBLE-BLIND RANDOMIZED CROSS-OVER TRIAL ASSESSING THE EFFICACY AND SAFETY OF STIMULATION OF THE CENTROMEDIAN NUCLEUS -SUBSTANTIA PERIVENTRICULARIS - NUCLEUS VENTRO-ORALIS INTERNUS CROSSPOINT IN THE THALAMUS FROM FEBRUARY 2005 TO 2009. AFTER SURGERY, THE PTS WERE RANDOMLY ASSIGNED TO 3 MONTHS STIMULATION FOLLOWED BY 3 MONTHS OFF STIMULATION (GROUP A) OR VICE VERSA (GROUP B). THE CROSS-OVER PERIOD WAS FOLLOWED BY 6 MONTHS ON STIMULATION. ASSESSMENTS WERE PERFORMED PRIOR TO SURGERY GAZE DISTURBANCES AND REDUCTION OF ENERGY LEVELS; THERE WERE NO REPORTS OF ANY SEXUAL PROBLEMS. THE AUTHORS REPORTED THAT UNBLINDED ADJUSTMENT OF THE STIMULATION PARAMETERS IMMEDIATELY AFTER SURGERY TOOK 3 WEEKS; ONE PT (PT 6) EXPERIENCED A COMPLEX EXPERIENCED THE MOST CHANGES BETWEEN ON AND OFF STIMULATION, WITH AN INCREASE IN OBSESSIVE-COMPULSIVE BEHAVIOR AND A DECREASE IN DEPRESSION AND ADHD SCORES DURING ON STIMULATION, AT 1 YEAR AFTER SURGERY, THIS PT SHOWED AN OVERALL IMPROVEMENT. THIS PT SHOWED A SUBSTANTIAL INCREASE IN TIME ON THE COLOR-WORD CARD OF THE STROOP; HOWEVER, MORE ERRORS WERE MADE AND AS SUCH SHOWED A DECLINE IN ACCURACY ON THIS SPECIFIC TEST. THIS PT SHOWED THE MOST DECLINE, IN PARTICULAR ON MENTAL SPEED AND EXPERIENCED VARYING MOTOR AND PSYCHIATRIC SYMPTOMS UP TO 1 YEAR AFTER OPERATION INCLUDING LETHARGY, BINGE EATING, DYSARTHRIA, APATHY, GAIT DISTURBANCES AND FREQUENT FALLS. ADJUSTMENT OF PARAMETER SETTINGS AND SWITCHING OFF THE STIMULATOR DID NOT AFFECT THESE SYMPTOMS. A CT-SCAN PERFORMED 6 MONTHS AFTER SURGERY IN ORDER TO EXCLUDE A DEVICE ISSUE REVEALED CEREBRAL ATROPHY THAT WAS ABSENT ON THE IMMEDIATE POSTOPERATIVE CT-SCAN AND PREOPERATIVE IMAGING. THIS PT WAS EXTENSIVELY RE-EVALUATED DURING THIS POSTOPERATIVE STAY ON A PSYCHIATRIC WARD AND AN EXTERNAL EXPERT WAS CONSULTED TO EXCLUDE POSSIBLE OTHER CO-MORBIDITIES. ALTHOUGH THE PT HAD A HISTORY OF ALCOHOL ABUSE, THERE WAS NO EXPLANATION FOUND FOR THE RAPIDLY PROGRESSIVE CEREBRAL ATROPHY. SEE MFR REPORT #3007566237-2011-07436.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O