BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 23749423 · Received December 8, 2025

    Report

    Report Number
    2182207-2025-03355
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    October 15, 2022
    Report Date
    December 8, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    DTB
    UDI-DI
    00681490116725
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 4968-35 LEAD IMPLANTED: ON (B)(6) 2009. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. REFERENCED ARTICLE: TRANSVENOUS ENDOCARDIAL CONDUCTION SYSTEM PACING IN PATIENTS WITH A FONTAN OPERATION. HEART RHYTHM CASE REPORTS. 2025. 11:1131¿1136. DOI: 10.1016/J.HRCR.2025.08.006. 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 TRANSVENOUS ENDOCARDIAL CONDUCTION SYSTEM PACING IN PATIENTS WITH A FONTAN OPERATION. THE AUTHORS DESCRIBED A PATIENT WHO UNDERWENT AN EPICARDIAL LEAD REVISION DUE TO A FRACTURE OF THE RIGHT ATRIAL (RA) LEAD AND HIGH THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. BOTH LEADS WERE CAPPED AND REPLACED. NO ADVERSE PATIENT EFFECTS OR ADDITIONAL PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2755290 CAPSURE EPICARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC NEUROMODULATION 4968-35 00681490116725

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Required Intervention| H W1DR01 IPG.