BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 24706182 · Received March 26, 2026

    Report

    Report Number
    2182207-2026-00819
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    December 5, 2025
    Report Date
    March 26, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    PJS
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: ENGELHARDT J, SIMON E, ZEMZEMI N, DALLIES-LABOURDETTE C, COURTIN E, SITTA R, BENARD A, BRANCHARD O, GOILLANDEAU M, LAURENCIN C, GERVAIS-BERNARD H, CAIRE C, THOBOIS S, TOURDIAS T, MUNSCH F, GUEHL D, CUNY E. ENHANCING ASLEEP DEEP BRAIN STIMULATION TARGETING FOR ESSENTIAL TREMOR USING MACHINE LEARNING: THE OPTIVIM PHASE 2 STUDY. NEUROSURGERY. 2025. DOI: 10.1227/NEU.0000000000 003870. A2 AGE: THE AGE PROVIDED REPRESENTS THE MEDIAN AGE OF THE STUDY, AS NO FURTHER DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. A3A SEX: THE SEX PROVIDED REPRESENTS THE MAJORITY OF THE STUDY GROUP, AS NO FURTHER DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. B2 OTHER: TRANSIENT ISCHEMIC STROKE B3: PLEASE NOTE THAT THE EVENT DATE IS BASED ON THE ARTICLE PUBLICATION DATE AT THIS TIME, AS NO FURTHER DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    1 PATIENT EXPERIENCED TRANSIENT APHASIA DUE TO A TRANSIENT ISCHEMIC STROKE. IT WAS NOTED THE ADVERSE EVENT WAS PROCEDURE RELATED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758826 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI PJS MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other "SEE H11...."