BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 23671248 · Received November 28, 2025

    Report

    Report Number
    MW5179464
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ELA / SORIN CRM SAS
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RIGHT VENTRICULAR (RV) LEAD UNDER-SENSING ON STORED ELECTROGRAMS (EGM). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220066 RV LEAD PERMANENT PACEMAKER ELECTRODE DTB ELA / SORIN CRM SAS P2 758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown