BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRIAL LEAD

    MDR report key: 19324354 · Received May 14, 2024

    Report

    Report Number
    MW5154919
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Report Date
    March 1, 2024
    Manufacturer
    SORIN CRM SAS
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEVICE APPEARS TO BE UNDER-SENSING ON ATRIAL LEAD. 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
    2520647 ATRIAL LEAD DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN CRM SAS P2P744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown