BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 23424743 · Received October 30, 2025

    Report

    Report Number
    2649622-2025-30468
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    March 27, 2023
    Report Date
    October 30, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    NVN
    UDI-DI
    00613994501745
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: INTEGRATED MULTIMODAL IMAGING FOR TRANSVENOUS TRANSPULMONARY ATRIAL PACING LEAD IMPLANTATION IN FONTAN PATIENT. JACC CASE REPORTS. 2025. 30:105286. DOI: 10.1016/J.JACCAS.2025.105286. 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 A PATIENT WHO HAD DEVELOPED PROTEIN-LOSING ENTEROPATHY (PLE) OWING TO LOW CARDIAC OUTPUT FROM BRADYCARDIA AND LACK OF ATRIOVENTRICULAR SYNCHRONY AFTER VENTRICULAR PACING LEAD FAILURE. THE AUTHORS DESCRIBED A PATIENT WHO PRESENTED TO THE EMERGENCY DEPARTMENT AFTER THEY HAD AN EVENT OF NEAR SYNCOPE AND A FALL WHILE WALKING, WITH ASSOCIATED VISUAL AURA, FATIGUE, LIGHTHEADEDNESS, AND EMESIS. PACEMAKER INTERROGATION SHOWED HIGH PACING IMPEDANCE ON THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD WITH NO SENSING OR CAPTURE. THE EPICARDIAL RIGHT ATRIAL (RA) LEAD HAD ALSO FAILED WITH A FRACTURE CONFIRMED VIA CHEST X-RAY. THE LEADS WERE CAPPED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298103 CAPSURE EPICARDIAL LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC PUERTO RICO VILLALBA 4965-25 00613994501745

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention| H PM2210 IPG, 4965-25 LEAD.