BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10184781 · Received June 23, 2020

    Report

    Report Number
    2182207-2020-00405
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    May 15, 2020
    Report Date
    June 23, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN. PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SERVELLO D, GALBIATI TF, BALESTRINO R, ET AL. DEEP BRAIN STIMULATION FOR GILLES DE LA TOURETTE SYNDROME: TOWARD LIMBIC TARGETS. BRAIN SCI. 2020;10(5). 10.3390/BRAINSCI10050301. GILLES DE LA TOURETTE SYNDROME (GTS) IS A COMPLEX NEURODEVELOPMENTAL DISORDER CHARACTERIZED BY TICS AND, FREQUENTLY, PSYCHIATRIC AND BEHAVIORAL COMORBIDITIES. ABOVE ALL, OBSESSIVE COMPULSIVE DISORDER/BEHAVIOR (OCD/OCB) INFLUENCES THE CLINICAL PICTURE AND HAS A SEVERE IMPACT ON QUALITY OF LIFE, EVENTUALLY MORE THAN THE TICS THEMSELVES. DEEP BRAIN STIMULATION (DBS) IS AN EFFECTIVE THERAPY IN SELECTED, REFRACTORY CASES. CLINICAL RESPONSE TO DBS MAY VARY ACCORDING TO THE CLINICAL PICTURE, COMORBIDITIES, AND TO THE ANATOMICAL TARGET. THIS RETROSPECTIVE STUDY COMPARES THE RESULTS OBTAINED FROM DBS IN THE VENTRALIS ORALIS/CENTROMEDIAN-PARAFASCICULAR NUCLEUS OF THE THALAMUS (VOI-CM/PF) (41 PATIENTS) AND ANTERO-MEDIAL GLOBUS PALLIDUS INTERNUS (AM-GPI) (14 PATIENTS), EVALUATING CLINICAL RESPONSE OVER TIME BY MEANS OF YALE GLOBAL TIC SEVERITY SCALE (YGTSS) AND YALE¿BROWN OBSESSIVE-COMPULSIVE SCALE (YBOCS) SCORES OVER A PERIOD OF 48 MONTHS. REPORTED EVENTS: PLI 10: SYSTEM REPORTING INS. PLI 20: 8 PATIENTS UNDERWENT ELECTRODE REMOVAL DUE TO SKIN EROSION AND INFECTION. PLI 30: 3 PATIENTS UNDERWENT ELECTRODE REMOVAL DUE TO POOR COMPLIANCE. IT WAS NOTED THERE WAS SCRATCHING OVER THE SURGICAL WOUNDS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649389 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention