BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 16816865 · Received April 26, 2023

    Report

    Report Number
    2182207-2023-00750
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 26, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MBX
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: THE PATIENT INFORMATION REFLECTS THE AVERAGE INFORMATION PROVIDED IN THE ARTICLE. B3: EVENT DATE BASED OFF THE DATE THE ARTICLE WAS PUBLISHED. 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

    OLACIREGUI DAGUE K, WITT J-A, VON WREDE R, HELMSTAEDTER C AND SURGES R (2023) DBS OF THE ANT FOR REFRACTORY EPILEPSY: A SINGLE CENTER EXPERIENCE OF SEIZURE REDUCTION, SIDE EFFECTS AND NEUROPSYCHOLOGICAL OUTCOMES. FRONT. NEUROL. 14:1106511. DOI: 10.3389/FNEUR.2023.110651 EVALUATION OF THE ANTISEIZURE EFFICACY, SIDE EFFECTS AND NEUROPSYCHOLOGICAL EFFECTS OF DEEP BRAIN STIMULATION (DBS) OF THE ANTERIOR NUCLEUS OF THE THALAMUS (ANT). ANT-DBS IS A TREATMENT OPTION FOR PATIENTS WITH DI CULT-TO-TREAT EPILEPSY. THE STUDY RETROSPECTIVELY ANALYZED THE DATA OF THE COHORT OF 13 PATIENTS. POST-IMPLANTATION SEIZURE FREQUENCIES WERE MEASURED AT 6 MONTHS, 12 MONTHS AND LAST FOLLOW-UP, AS WELL AS AVERAGED THROUGHOUT FOLLOW-UP. THESE VALUES WERE THEN COMPARED WITH MEAN SEIZURE FREQUENCIES IN THE 6 MONTHS BEFORE IMPLANTATION. REPORTED EVENTS: 8 ELECTRODES WERE FOUND TO BE OUTSIDE OF THE IMPLANT LOCATION. 2 LEADS REQUIRED REVISION.  1 PATIENT EXPERIENCED DELUSIONAL DISORDER. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477080 ACTIVA Stimulator, thalamic, epilepsy, implanted MBX MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention