BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRIAL LEAD

    MDR report key: 17514879 · Received August 11, 2023

    Report

    Report Number
    MW5123032
    Event Type
    Other
    Date Received
    August 11, 2023
    Report Date
    August 1, 2023
    Manufacturer
    OSCOR, INC.
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    P-WAVES MEASURE 0.1MV AND SENSITIVITY IS PROGRAMMED 0.15MV. POSSIBLE ATRIAL OVER-SENSING/UNDER-SENSING NOTED. DEVICE IS INAPPROPRIATELY MODE SWITCHED AND MISCLASSIFYING AT/AF EPISODES; (B)(4) DEVICE CLASSIFIED MONITORED AT/AF EPISODES MOST RECENT ON 19- JUN-2023 CURRENTLY IN PROGRESS, CURRENT EGM SHOWS ATRIAL OVER-SENSING INAPPROPRIATELY MODE SWITCHED. REFERENCE REPORT THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5123031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707294 ATRIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB OSCOR, INC. 4017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown