BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 19417737 · Received May 28, 2024

    Report

    Report Number
    MW5155500
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    November 24, 2020
    Report Date
    April 1, 2024
    Manufacturer
    ABBOTT MEDICAL / ST. JUDE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2020 15:00:11 *RV (RIGHT VENTRICULAR) BIPOLAR LEAD IMPEDANCE >3000 OHMS. 3000 OHMS 12-(B)(6) 2017 12:38:22 *RV LEAD INTEGRITY WARNING: SENSING INTEGRITY COUNTER >= 30 IN 3 DAYS. RV LEAD IMPEDANCE VARIATION IN LAST 60 DAYS. (B)(6) 2017 09:00:12 *RV BIPOLAR LEAD IMPEDANCE >3000 OHMS. 3000 OHMS (B)(6) 2016 21:00:11 *RV BIPOLAR LEAD IMPEDANCE 2014 OHMS. 2000 OHMS (B)(6) 2016 15:00:11 *RV BIPOLAR LEAD IMPEDANCE 1615 OHMS. 1500 OHMS (B)(6) 2016 15:00:10 *RV BIPOLAR LEAD IMPEDANCE 1482 OHMS. 1000 OHMS. 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
    298871 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ABBOTT MEDICAL / ST. JUDE 7121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown