BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT VENTRICULAR LEAD

    MDR report key: 19383961 · Received May 22, 2024

    Report

    Report Number
    MW5155309
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT IS REMOTE TO FOLLOW UP, NO WEIGHT OBTAINED. Q: IS THERE AN ISSUE WITH THE RV (RIGHT VENTRICULAR) LEAD WHEN TTC IMPEDANCE IS BELOW 200 OHMS? D: RV LEAD IMPEDANCE ALERT IS PROGRAMMED OFF. RV TTC IMPEDANCES ARE B/T (BETWEEN) 171 AND 190 OHMS. ST. JUDE 1580 LEAD WAS IMPLANTED IN 2003. AT GEN (GENERATOR) CHANGE IN 2018, RV TTC IMPEDANCES WERE B/T 200 AND 250 OHMS. RV LEAD IS SENSING BIPOLAR. R: THERE HAS BEEN A SLIGHT DROP IN THE RV BIPOLAR AND RV TTC IMPEDANCES SINCE GEN CHANGE BUT AT THIS TIME, THEY REMAIN STABLE. 0 SIC (SENSING INTEGRITY COUNTER) SINCE (B)(6) 2023. DISCUSSED WITH CALLER THAT WHEN PATIENT IS SEEN IN CLINIC, PERFORM ISOMETRICS AND POCKET MANIPULATION TO ENSURE NO OVERSENSING ON THE LEAD. THE LOW IMPEDANCE COULD BE INDICATIVE OF AN INSULATION ISSUE THAT MAY WORSEN AT GEN CHANGE. CONTINUE TO MONITOR THE LEAD CLOSELY AND ASSESS FOR ADDITIONAL CHANGES IN LEAD IMPEDANCES, SIC COUNTS, SENSING AND PACING 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
    2300949 RIGHT VENTRICULAR LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. 1580-65

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown