BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMEDICS / BOSTON SCIENTIFIC CORPORATION

    MDR report key: 19324427 · Received May 14, 2024

    Report

    Report Number
    MW5154921
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Report Date
    March 1, 2024
    Manufacturer
    INTERMEDICS / BOSTON SCIENTIFIC CORPORATION
    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

    RV LEAD IMPEDANCE ISSUES SINCE DEVICE IMPLANT IN 2019. HIGH RV THRESHOLD ALSO. 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
    2520649 INTERMEDICS / BOSTON SCIENTIFIC CORPORATION PERMANENT PACEMAKER ELECTRODE DTB INTERMEDICS / BOSTON SCIENTIFIC CORPORATION 435-05 LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown