BEUDAMED
    FDA Adverse Event Death Summary report: N

    RA LEAD

    MDR report key: 19310610 · Received May 13, 2024

    Report

    Report Number
    MW5154795
    Event Type
    Death
    Date Received
    May 13, 2024
    Date of Event
    January 25, 2024
    Report Date
    March 1, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INTERFACE UPDATE, PATIENT STATUS UPDATED TO EXPIRED. ONLINE OBITUARY NOTED PATIENT DECEASED ON THE (B)(6) 2024. ALLEGATION RELATES TO NON-CAPTURE ON THE RIGHT ATRIAL (RA) LEAD ON THE PRESENTING ELECTROGRAMS (EGM) FOUR DAYS PRIOR PASSING. 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
    618517 RA LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR INC. ZY52JUSBV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death