BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2842581 · Received November 21, 2012

    Report

    Report Number
    3007566237-2012-02811
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    September 9, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    PORTA, M., SERVELLO, D., ZANABONI, C., ANASETTI, F., MENGHETTI, C., SASSI, M., ROBERTSON, M. M. DEEP BRAIN STIMULATION FOR TREATMENT OF REFRACTORY TOURETTE SYNDROME: LONG-TERM FOLLOW-UP. ACTA NEUROCHIR. (WIEN). 2012;154(11): 2029-2041. DOI: 10.1007/S00701-012-1497-8. SUMMARY: EIGHTEEN PATIENTS WITH SEVERE AND REFRACTORY TOURETTE SYNDROME UNDERWENT BILATERAL THALAMIC DEEP BRAIN STIMULATION. THE SURGICAL PROCEDURES AND STIMULATION PROCESSES OF THE COHORT WERE REPORTED IN 2008; THE 2 YEAR FOLLOW-UP WAS REPORTED IN 2009. THE AIM OF THE RESEARCH IS THE ASSESSMENT OF LONG-TERM OUTCOME (5-6 YEARS) ON TICS, OBSESSIONAL BEHAVIOURS, ANXIETY, MOOD, AND ON THE OVERALL GENERAL HEALTH OF THE PATIENTS AND THEIR GENERAL SATISFACTION. IN THIS STUDY, ALL 18 OF THE ORIGINAL PATIENTS WILL BE DISCUSSED, PRE- AND POST-DBS, ACCORDING TO OUR PROTOCOL USING STANDARDIZED OBJECTIVE SCHEDULES, AS WELL AS THE CLINICAL IMPRESSIONS OF BOTH CLINICIANS AND PATIENTS. AS THERE WERE NO SUBSTANTIAL NOR STATISTICAL DIFFERENCES ON MEASURES OF COGNITIVE FUNCTIONING BETWEEN PRE-DBS AND 2 YEAR FOLLOWUP, WE DECIDED NOT TO CONTINUE THIS ASPECT OF THE FORMAL ASSESSMENT, PARTICULARLY AS THERE WERE ALSO NO CLINICAL INDICATIONS. AT 5-6 YEAR FOLLOW-UP, THERE WAS A SIGNIFICANT REDUCTION IN TIC SEVERITY (P<(><<)>(><(><<)><(><<)>)>0.001), AND SIGNIFICANT IMPROVEMENTS IN OBSESSIVE COMPULSIVE BEHAVIOURS (P00.003), ANXIETY (P<(><<)>(> <(><<)><(><<)>)>0.001) AND DEPRESSIVE (P <(><<)>(><(><<)><(><<)>)>0.001) SYMPTOMS. PATIENTS, IN GENERAL, REQUIRED LESS MEDICATION FOR TICS, COMORBID CONDITIONS AND/OR CO-EXISTENT PSYCHOPATHOLOGIES. THE LONG-TERM OUTCOME/SATISFACTION WERE NOT UNANIMOUS BETWEEN PATIENTS AND THE MEDICAL TEAM. AT LONG-TERM FOLLOW-UP, DBS WAS VERY SUCCESSFUL IN TERMS OF A SIGNIFICANT IMPROVEMENT IN TICS AND ALSO A SIGNIFICANT REDUCTION IN THE POTENTIALLY DISABLING SYMPTOMS OF OBSESSIONALITY, ANXIETY AND DEPRESSION. HOWEVER, COMPARED WITH OUR MORE POSITIVE OVERALL RESULTS AT 2 YEARS, THESE LATER RESULTS DEMONSTRATE LONG-TERM DIFFICULTIES AS FOLLOWS: NON-COMPLIANCE, LONG-TERM COMPLICATIONS , AND THE DIFFERENCES IN THE OPINIONS BETWEEN THE MEDICAL, THE SURGICAL TEAMS AND THE POST-DBS PATIENTS AS TO THEIR OUTCOME/SATISFACTION WITH THE PROCEDURES. OUR EXPERIENCE HIGHLIGHTS THE NEED FOR CONTROLLED STUDIES, FOR LONG-TERM FOLLOW UP, AND THE NEED TO IMPROVE THE SELECTION OF PATIENTS FOR DBS. REPORTED EVENT: A (B)(6) MALE EXPERIENCED AN ABDOMINAL WALL HEMATOMA. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    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 00046 YR Required Intervention