BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRIAL LEAD

    MDR report key: 19417334 · Received May 28, 2024

    Report

    Report Number
    MW5155492
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEVICE APPEARS TO BE OVERSENSING ON THE ATRIAL LEAD RESULTING IN INAPPROPRIATE AT/AF (ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION) EVENTS. FYI REP. 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
    331888 ATRIAL LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. 2088TC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown