BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5983452 · Received September 28, 2016

    Report

    Report Number
    3007566237-2016-03403
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    January 1, 2016
    Report Date
    September 28, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    HAUSEUX, P.A., CYPRIEN, F., CIF, L., GONZALEZ, V., BOULENGER, J-P., COUBES, P., CAPDEVIELLE, D. LONG-TERM FOLLOW-UP OF PALLIDAL DEEP BRAIN STIMULATION IN TEENAGERS WITH REFRACTORY TOURETTE SYNDROME AND COMORBID PSYCHIATRIC DISORDERS: ABOUT THREE CASES. EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY : EJPN : OFFICIAL JOURNAL OF THE EUROPEAN PAEDIATRIC NEUROLOGY SOCIETY. 2016. 1090 (1-4). DOI: 10.1016/J.EJPN.2016.06.005 SUMMARY: THE AIM OF THE STUDY WAS TO ASSESS THE LONG-TERM RISK-BENEFIT RATIO OF PALLIDAL DEEP BRAIN STIMULATION (DBS) FOR YOUNG PATIENTS WITH REFRACTORY TOURETTE SYNDROME (TS) AND SEVERE COMORBID PSYCHIATRIC DISORDERS. REPORTED EVENTS: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL POSTEROVENTRAL GLOBUS PALLIDUS INTERNUS (GPI) AND GLOBUS PALLIDUS EXTERNUS (GPE) DEEP BRAIN STIMULATION (DBS) IMPLANT IN (B)(6) 2010 FOR MEDICATION-RESISTANT TOURETTE SYNDROME (TS) ASSOCIATED WITH SEVERE OBSESSIVE-COMPULSIVE DISORDER (OCD) (SYMMETRY OBSESSIONS AND COUNTING MENTAL COMPULSIONS), ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD), ANXIETY-DEPRESSIVE DISORDER, AND IMPULSE CONTROL DISORDER (ICD). POSTOPERATIVE MRI CHECKED ELECTRODE POSITION. DESPITE REDUCTION OF MOTOR TICS AFTER DBS OF POSTEROVENTRAL GPI AND GPE, THE PATIENT SUBSEQUENTLY SUFFERED FROM WORSENING OF ANXIETY-DEPRESSIVE AND IMPULSIVE (ACUTE DRUG SELF-INDUCED OVERDOSES) DISORDERS. THESE MOOD FLUCTUATIONS WERE EMPIRICALLY IMPUTED TO GPE DBS. HOWEVER, THE PATIENT REPORTED BETTER QUALITY OF LIFE OR GREATER SOCIAL INCLUSION SINCE DBS. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED IN THE ARTICLE: LEAD MODEL 3389; IMPLANTABLE NEUROSTIMULATOR KINETRA MODEL 7428; IMPLANTABLE NEUROSTIMULATOR ACTIVA PC MODEL 37601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635003 UNKNOWN IMPLANTABLE NEUROSTIMULATOR MFR MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening