BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPSILA EV¿ MRI SURESCAN¿

    MDR report key: 24607203 · Received March 16, 2026

    Report

    Report Number
    2182208-2026-10021
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    August 1, 2025
    Report Date
    March 16, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVY
    PMA / PMN Number
    P220012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE BASELINE AGE CHARACTERISTICS IS 61 YEARS OLD. WITHOUT A SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: MANAGING OVERSENSING IN EXTRAVASCULAR ICDS: LESSONS FROM CLINICAL EXPERIENCE. CIRCULATION: ARRHYTHMIA AND ELECTROPHYSIOLOGY. 2025. 18:E014071. DOI: 10.1161/CIRCEP.125.014071 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

    LITERATURE WAS REVIEWED REGARDING OVERSENSING IN EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (EV-ICDS). THE AUTHORS DESCRIBED FOUR PATIENTS WHO UNDERWENT EV-ICD IMPLANTS. EACH OF THE FOUR PATIENTS HAD LEADS WHICH EXHIBITED OVERSENSING. THE FIRST LEAD EXHIBITED MULTIPLE NON-SUSTAINED VENTRICULAR TACHYCARDIA AND VENTRICULAR OVERSENSING-NOISE EPISODES AND IMPEDANCE ROSE ABRUPTLY. THE THERAPY WAS TEMPORARILY DEACTIVATED AND THE OVERSENSING RESOLVED WITHIN TWENTY-FOUR HOURS. IT WAS SUSPECTED THE OVERSENSING WAS CAUSED BY AIR ENTRAPMENT DURING IMPLANTATION. THE SECOND PATIENT EXPERIENCED AN INAPPROPRIATE SHOCK DURING ATRIAL TACHYCARDIA DUE TO P-WAVE OVERSENSING. THE NEXT LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AFTER A SIGNIFICANT DECREASE IN R-WAVE AMPLITUDE. THE FOURTH LEAD EXHIBITED OVERSENSING OF MYOPOTENTIALS. ALL LEADS WERE REPROGRAMMED AND REMAIN IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668236 EPSILA EV¿ MRI SURESCAN¿ PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC, INC. EV240163

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention| L DVEA3E4 ICD