BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7630746 · Received June 22, 2018

    Report

    Report Number
    3007566237-2018-01867
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    March 1, 2014
    Report Date
    September 26, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED FOR TREATMENT OF TOURETTE SYNDROME. THE REPORTED EVENTS WERE FROM THE FOLLOWING LITERATURE ARTICLE: SMEETS AYJM, DUITS AA, HORSTKÖTTER D, VERDELLEN C, DE WERT G, TEMEL Y, ACKERMANS L, LEENTJENS AFG. ETHICS OF DEEP BRAIN STIMULATION IN ADOLESCENT PATIENTS WITH REFRACTORY TOURETTE SYNDROME: A SYSTEMATIC REVIEW AND TWO CASE DISCUSSIONS. NEUROETHICS DOI: 10.1007/S12151-018-9359-6. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED VIA THE FOLLOWING LITERATURE ARTICLE: SMEETS AYJM, DUITS AA, HORSTKÖTTER D, VERDELLEN C, DE WERT G, TEMEL Y, ACKERMANS L, LEENTJENS AFG. ETHICS OF DEEP BRAIN STIMULATION IN ADOLESCENT PATIENTS WITH REFRACTORY TOURETTE SYNDROME: A SYSTEMATIC REVIEW AND TWO CASE DISCUSSIONS. NEUROETHICS DOI: 10.1007/S1 2151-018-9359-6 ABSTRACT: TOURETTE SYNDROME (TS) IS A CHILDHOOD ONSET DISORDER CHARACTERIZED BY VOCAL AND MOTOR TICS AND OFTEN REMITS SPONTANEOUSLY DURING ADOLESCENCE. FOR TREATMENT OF REFRACTORY PATIENTS, DEEP BRAIN STIMULATION (DBS) MAY BE CONSIDERED. WE DISCUSS ETHICAL PROBLEMS ENCOUNTERED IN TWO ADOLESCENT TS PATIENTS TREATED WITH DBS AND SYSTEMATICALLY REVIEW THE LITERATURE ON THE TOPIC. FOLLOWING SURGERY ONE PATIENT EXPERIENCED SIDE EFFECTS WITHOUT SUFFICIENT THERAPEUTIC EFFECTS AND THE STIMULATOR WAS TURNED OFF. AFTER A SECOND SERIES OF BEHAVIORAL TREATMENT, HE EXPERIENCED A TIC REDUCTION OF MORE THAN 50%. THE SECOND PATIENT WENT THROUGH A PERIOD OF BEHAVIORAL DISTURBANCES THAT INTERFERED WITH OPTIMAL PROGRAMMING, BUT EVENTUALLY EXPERIENCED A 70% TIC REDUCTION. SIXTEEN DBS SURGERIES IN ADOLESCENT TS PATIENTS HAVE BEEN REPORTED, NONE OF WHICH PAYS ATTENTION TO ETHICAL ASPECTS. SPECIFIC ETHICAL ISSUES ARISE IN ADOLESCENT TS PATIENTS UNDERGOING DBS RELATING BOTH TO CLINICAL PRACTICE AS WELL AS TO RESEARCH. ATTENTION SHOULD BE PAID TO SELECTING PATIENTS FAIRLY, THROUGH EXAMINATION AND WEIGHING OF RISKS AND BENEFITS, PROTECTING THE HEALTH OF CHILDREN AND ADOLESCENTS RECEIVING DBS, SPECIAL ISSUES CONCERNING PATIENT¿S AUTONOMY, AND THE NORMATIVE IMPACT OF QUALITY OF LIFE. IN RESEARCH, REGISTRATION OF ALL TS CASES IN A CENTRAL DATABASE COVERING A RANGE OF STANDARDIZED INFORMATION WILL FACILITATE FURTHER DEVELOPMENT OF DBS FOR THIS INDICATION. CLINICAL PRACTICE SHOULD BE ACCOMPANIED BY ONGOING ETHICAL REFLECTION, PREFERABLY COVERING NOT ONLY THEORETICAL THOUGHT BUT PROVIDING ALSO INSIGHTS IN THE VIEWS AND PERSPECTIVES OF THOSE CONCERNED, THAT IS PATIENTS, FAMILY MEMBERS AND PROFESSIONALS. REPORTED EVENT: ONE (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT BILATERAL ANTERIOR INTERNAL GLOBUS PALLIDUS (GPI) DEEP BRAIN STIMULATION (DBS) IN MARCH 2014 FOR TREATMENT OF TICS DUE TO TOURETTE SYNDROME (TS). IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED TICS SINCE THE AGE OF FIVE AND HAD NO OTHER DISEASE OR COMORBIDITIES. A FEW DAYS AFTER SURGERY, THE STIMULATOR WAS TURNED ON AND DIFFERENT CONTACT POINTS AND STIMULATION PARAMETERS WERE TESTED. WITH INCREASING VOLTAGES, THE PATIENT EXPERIENCED SIDE EFFECTS SUCH AS HYPERKINESIA, DYSKINESIA IN THE LEGS, AND A DEJECTED MOOD, COMPLICATING THE PROGRAMMING. THEREFORE, THE VOLTAGE WAS REDUCED BEFORE HE WAS DISCHARGED, ACCEPTING A SUBOPTIMAL TIC REDUCTION AT THAT MOMENT. THE EXPECTATION WAS THAT THESE SIDE EFFECTS WOULD DIMINISH DUE TO HABITUATION AND THAT THE VOLTAGE COULD BE INCREASED SLOWLY AT THE OUTPATIENT DEPARTMENT. HOWEVER, AFTER SIX MONTHS OF INTENSIVE OUTPATIENT VISITS AND A SECOND ADMISSION AT THE HOSPITAL TO SYSTEMATICALLY CHECK ALL POSSIBLE STIMULATION PARAMETERS, HE STILL EXPERIENCED THE SAME SIDE EFFECTS AT ALL CONTACTS WITHOUT SUFFICIENT THERAPEUTIC EFFECTS. IT WAS DECIDED TO TURN THE STIMULATOR OFF. AT THAT TIME, HIS SCORE ON THE YALE GLOBAL TIC SEVERITY SCALE (YGTSS) WAS 24, WHICH WAS A RELEVANT REDUCTION COMPARED TO THE PREOPERATIVE SCORE. HOWEVER, HE STILL SUFFERED FROM SEVERE TICS, SUCH AS CONSTANTLY LOUD BARKING AND HEADSHAKING; HE FELT ASHAMED AND AVOIDED SOCIAL ACTIVITIES. IN SEPTEMBER 2016, AT THE AGE OF (B)(6), HE STARTED BEHAVIOR THERAPY FOR 3 MONTHS WITH A FURTHER RELEVANT IMPROVEMENT IN TICS, SELF-CONFIDENCE, AND OVERALL FUNCTIONING. AT THE TIME OF PUBLICATION, THE PATIENT DID NOT WANT THE STIMULATOR REMOVED AS HE EXPERIENCED NO BURDENS AND DID NOT WANT TO UNDERGO SURGERY AGAIN. THERE WAS NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR REPORTED THAT THE ADVERSE EVENTS WERE NOT RELATED TO MEDTRONIC PRODUCTS; THAT WHILE THE ADVERSE EVENTS OCCURRED DURING SETUP OF SETTINGS BUT THEY REPORTED THIS HAD NOTHING TO DO WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THEY ADDED THAT THE PATIENT NO LONGER HAD AN INS BECAUSE THEY NO LONGER NEEDED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471043 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization