BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX SR 45

    MDR report key: 19416359 · Received May 28, 2024

    Report

    Report Number
    MW5155476
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    February 27, 2024
    Report Date
    April 1, 2024
    Manufacturer
    BKC (BIOTRONIK, INC.) / BIOTRONIK SE & CO. KG
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THREE HUNDRED FORTY-FIVE MONITORED AT/AF EPISODES, MOST RECENT ONGOING SINCE (B)(6) 2024. INTERMITTENT ATRIAL UNDER-SENSING OBSERVED ON THESE EPISODES, LEADING TO EARLY TERMINATION OF EPISODE COLLECTION. DDIR MODE. NOT AFFECTING DEVICE FUNCTION. 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
    331872 SELOX SR 45 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN BKC (BIOTRONIK, INC.) / BIOTRONIK SE & CO. KG 343081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown