BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 17306065 · Received July 12, 2023

    Report

    Report Number
    2182207-2023-01348
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    April 27, 2023
    Report Date
    July 12, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VILELA-FILHO O., SOUZA J., RAGAZZO P., SILVA D., OLIVEIRA P., GOULART L., REIS M., PIEDIMONTE F., RIBEIRO T. BILATERAL GLOBUS PALLIDUS EXTERNUS DEEP BRAIN STIMULATION FOR THE TREATMENT OF REFRACTORY TOURETTE SYNDROME: AN OPEN CLINICAL TRIAL INTERNATIONAL NEUROMODULATION SOCIETY 2023 DOI: 10.1016/J.NEUROM.2023.04.473 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. D.2. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION; SEE B5. CONTINUATION OF D10: PRODUCT ID: 37612, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37612. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    VILELA-FILHO O., SOUZA J., RAGAZZO P., SILVA D., OLIVEIRA P., GOULART L., REIS M., PIEDIMONTE F., RIBEIRO T. BILATERAL GLOBUS PALLIDUS EXTERNUS DEEP BRAIN STIMULATION FOR THE TREATMENT OF REFRACTORY TOURETTE SYNDROME: AN OPEN CLINICAL TRIAL INTERNATIONAL NEUROMODULATION SOCIETY 2023 DOI: 10.1016/J.NEUROM.2023.04.473 ABSTRACT: OBJECTIVES: WE HAVE PREVIOUSLY PROPOSED THAT TOURETTE SYNDROME (TS) IS THE CLINICAL EXPRESSION OF THE HYPERACTIVITY OF GLOBUS PALLIDUS EXTERNUS (GPE) AND VARIOUS CORTICAL AREAS. THIS STUDY WAS DESIGNED TO TEST THIS HYPOTHESIS BY VERIFYING THE EFFICACY AND SAFETY OF BILATERAL GPE DEEP BRAIN STIMULATION (DBS) FOR TREATING REFRACTORY TS. MATERIALS AND METHODS: IN THIS OPEN CLINICAL TRIAL, 13 PATIENTS WERE OPERATED ON. TARGET COORDINATES (CENTER OF GPE) WERE OBTAINED BY DIRECT VISUALIZATION. PHYSIOLOGICAL MAPPING WAS PERFORMED WITH MACROSTIMULATION AND MICRORECORDING. PRIMARY AND SECONDARY OUTCOME MEASURES WERE, RESPECTIVELY, RESPONDER AND IMPROVEMENT RATES OF TS AND COMORBIDITIES, ACCORDING TO PRE AND POSTOPERATIVE SCORES ON THE FOLLOWING ASSESSMENT INSTRUMENTS: YALE GLOBAL TIC SEVERITY SCALE, YALE-BROWN OBSESSIVE COMPULSIVE SCALE, BECK DEPRESSION INVENTORY/HAMILTON DEPRESSION RATING SCALE, BECK ANXIETY INVENTORY/HAMILTON ANXIETY RATING SCALE, AND CONCENTRATED ATTENTION TEST. RESULTS: INTRAOPERATIVE STIMULATION (100 HZ/5.0V) DID NOT PRODUCE ANY ADVERSE EFFECTS OR IMPACT ON TICS. MICRO RECORDING REVEALED BURSTING CELLS DISCHARGING SYNCHRONOUSLY WITH TICS IN THE CENTRAL PART OF THE DORSAL HALF OF GPE. PATIENTS WERE FOLLOWED UP FOR A MEAN OF 61.46±48.50 MONTHS. RESPONDER RATES WERE 76.9%, 75%, 71.4%, 71.4%, AND 85.7%, RESPECTIVELY, FOR TS, OBSESSIVE COMPULSIVE DISORDER (OCD), DEPRESSION, ANXIETY, AND ATTENTION DEFICIT HYPERACTIVITY DISORDER. MEAN IMPROVEMENTS AMONG RESPONDERS IN TS, OCD, DEPRESSION, AND ANXIETY WERE 77.4%, 74.7%, 89%, AND 84.8%, RESPECTIVELY. AFTER STARTING STIMULATION, TIC IMPROVEMENT WAS USUALLY DELAYED, TAKING UP TO TEN DAYS TO MANIFEST. AFTERWARD, IT INCREASED OVER TIME, USUALLY REACHING ITS MAXIMUM AT APPROXIMATELY ONE YEAR POSTOPERATIVELY. THE BEST STIMULATION PARAMETERS WERE 2.3V TO 3.0V, 90 TO 120 ¿SEC, AND 100 TO 150 HZ, AND THE MOST EFFECTIVE CONTACTS WERE THE TWO DORSAL ONES. TWO COMPLICATIONS WERE REGISTERED: REVERSIBLE IMPAIRMENT OF PREVIOUS DEPRESSION AND TRANSIENT UNILATERAL BRADYKINESIA. CONCLUSIONS: BILATERAL GPE-DBS PROVED TO BE LOW RISK AND QUITE EFFECTIVE FOR TREATING TS AND COMORBIDITIES, RATIFYING THE PATH PHYSIOLOGICAL HYPOTHESIS THAT LED TO THIS STUDY. MOREOVER, IT COMPARED FAVORABLY WITH DBS OF OTHER TARGETS CURRENTLY IN USE. REPORTED EVENTS: 1) 1 PATIENT (PATIENT 3) EXPERIENCED A SURGICAL COMPLICATION, BILATERAL PERI ELECTRODE EDEMA. THE PATIENT ALSO HAD TRANSIENT MILD BRADYKINESIA ON THE RIGHT UPPER LIMB 2) PATIENT 12 DECIDED AFTER A FEW MONTHS, FEELING MUCH BETTER TO NOT CHARGE THE IMPLANTABLE NEUROSTIMULATOR ANYMORE. IT WAS THEN NOT POSSIBLE TO REACTIVATE THE IMPLANTABLE NEUROSTIMULATOR ANYMORE AND THE PATIENT DECIDED NOT TO REPLACE THE IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190442 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention "SEE H10...."