BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 18591863 · Received January 26, 2024

    Report

    Report Number
    2182207-2024-00308
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    December 15, 2023
    Report Date
    January 26, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    PJS
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    DOMINIQUE GUEHL, ETIENNE GUILLAUD, NICOLAS LANGBOUR, EMILIE DOAT, NICOLASAUZOU, EDOUARD COURTIN, OLIVIER BRANCHARD, JULIEN ENGELHARDT, ABDELHAMID BENAZZOUZ, ALEXANDRE EUSEBIO, EMMANUEL CUNY <(>&<)> PIERRE BURBAUD. USEFULNESS OF THALAMIC BETA ACTIVITY FOR CLOSED-LOOP THERAPY IN ESSENTIAL TREMOR. SCIENTIFIC REPORT JOURNAL. DOI: 10.1038/S41598-023-49511-5. A PARTIAL LOSS OF EFFECTIVENESS OF DEEP BRAIN STIMULATION OF THE VENTRAL INTERMEDIATE NUCLEUS OF THE THALAMUS (VIM) HAS BEEN REPORTED IN SOME PATIENTS WITH ESSENTIAL TREMOR (ET), POSSIBLY DUE TO HABITUATION TO PERMANENT STIMULATION. THIS STUDY FOCUSED ON THE EVOLUTION OF VIM LOCAL-FIELD POTENTIALS (LFPS) DATA OVER TIME TO ASSESS THE LONG-TERM FEASIBILITY OF CLOSED-LOOP THERAPY BASED ON THALAMIC ACTIVITY. WE PERFORMED RECORDINGS OF THALAMIC LFPS IN 10 PATIENTS WITH SEVERE ET USING THE ACTIVA¿ PC+S (MEDTRONIC PLC.) ALLOWING BOTH RECORDINGS AND STIMULATION IN THE SAME REGION. PARTICULAR ATTENTION WAS PAID TO DESCRIBING THE EVOLUTION OF LFPS OVER TIME FROM 3 TO 24 MONTHS AFTER SURGERY WHEN THE STIMULATION WAS OF. WE DEMONSTRATED A SIGNIFICANT DECREASE IN HIGH-BETA LFPS AMPLITUDE DURING MOVEMENTS INDUCING TREMOR IN COMPARISON TO THE REST CONDITION 3 MONTHS AFTER SURGERY (1.91 ± 0.89 AT REST VS. 1.27 ± 1.37 V2 /HZ DURING POSTURE/ACTION FOR N= 8/10 PATIENTS; P= 0.010), 12 MONTHS AFTER SURGERY (2.92 ± 1.75 AT REST VS. 2.12 ± 1.78 V2 /HZ DURING POSTURE/ACTION FOR N= 7/10 PATIENTS; P= 0.014) AND 24 MONTHS AFTER SURGERY (2.32 ± 0.35 AT REST VS 0.75 ± 0.78 V2 / HZ DURING POSTURE/ACTION FOR 4/6 PATIENTS; P= 0.017). AMONG THE PATIENTS WHO EXHIBITED A SIGNIFICANT DECREASE OF HIGH-BETA LFP AMPLITUDE WHEN STIM ULATION WAS OF, THIS PHENOMENON WAS OBSERVED AT LEAST TWICE DURING THE FOLLOW-UP. ALTHOUGH THE EXTENT OF THIS DECREASE IN HIGH-BETA LFPS AMPLITUDE DURING MOVEMENTS INDUCING TREMOR MAY VARY OVER TIME, THIS THALAMIC BIOMARKER OF MOVEMENT COULD POTENTIALLY BE USABLE FOR CLOSED-LOOP THERAPY IN THE LONG TERM.   REPORTED EVENTS: IT WAS REPORTED THAT TWO PATIENTS IMPLANTED FOR ESSENTIAL TREMOR HAD HIGH IMPEDANCES >40,000 OHMS SEEN ON CONTACTS E10 AND E3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848457 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI PJS MEDTRONIC NEUROMODULATION 37604

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown "SEE H10...."