BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGM

    MDR report key: 17537421 · Received August 12, 2023

    Report

    Report Number
    MW5144299
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    August 6, 2020
    Report Date
    September 8, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    VENTRICULAR UNDERSENSING NOTED ON EGM. 19 VT NON-SUSTAINED EPISODES MOST RECENT ON 06-AUG-2020 AT 23:31. VENTRICULAR UNDERSENSING NOTED ON EGM 1142. PWAVES MEASURE 0.4 MV AND SENSITIVITY IS PROGRAMMED 0.3 MV. POTENTIAL FOR ATRIAL UNDER SENSING. 603892327. 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
    1084996 EGM PERMANENT DEFIBRILLATOR ELECTRODES NVY ST. JUDE MEDICAL 7120Q AND 1888TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR R