BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 23015328 · Received September 10, 2025

    Report

    Report Number
    2182208-2025-04523
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    UDI-DI
    00681490383653
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: FEASIBILITY OF LEFT BUNDLE BRANCH AREA PACING WITH LEFT AXILLARY PACEMAKER IMPLANTATION IN A YOUNG FEMALE PATIENT WITH HEART FAILURE. JOURNAL OF ARRHYTHMIA. 2025. 41: E70022. DOI: 10.1002/JOA3.70022. CONTINUATION OF D10: 4965-35 LEAD, IMPLANTED: (B)(6) 2007. 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 LEFT BUNDLE BRANCH AREA PACING WITH LEFT AXILLARY IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION. THE AUTHORS DESCRIBED A PATIENT WHO EXPERIENCED PACING INDUCED CARDIOMYOPATHY RELATED TO A LEFT VENTRICULAR (LV) EPICARDIAL LEAD WHICH EXHIBITED SIGNS OF FRACTURE WITH AN INCREASE IN IMPEDANCE. THE LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506800 CAPSURE EPICARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 4968-35 00681490383653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R ADDRL1 IPG