BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 18038729 · Received October 27, 2023

    Report

    Report Number
    MW5147485
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    October 5, 2021
    Report Date
    October 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2021, 15:00:05: *SVC DEFIB LEAD IMPEDANCE 132 OHMS. THRESHOLD 130 OHMS. (B)(6) 2023, 21:00:04: *SVC DEFIB LEAD IMPEDANCE 165 OHMS. THRESHOLD 160 OHMS. (B)(6) 2023, 03:05:30: *RV (RIGHT VENTRICULAR) LEAD INTEGRITY WARNING: 2 OR MORE HIGH RATE-NS (NORMAL SINUS RHYTHM) EPISODES < 220 MS. SENSING INTEGRITY COUNTER >= 30 IN 3 DAYS. (B)(6) 2023, 09:00:01: *RV BIPOLAR LEAD IMPEDANCE >3000 OHMS. THRESHOLD 3000 OHMS. (B)(6) 2023, 15:24:22: RV LEAD INTEGRITY WARNING: 2 OR MORE HIGH RATE-NS EPISODES < 220 MS. SENSING INTEGRITY COUNTER >= 30 IN 3 DAYS. (B)(6) 2023, 21:00:01: *RV BIPOLAR LEAD IMPEDANCE >3000 OHMS. THRESHOLD 3000 OHMS. APPEARS TO BE OVERSENSING NOTED ON STORED EGM (ELECTROGRAM) EPISODES. 15 VT (VENTRICULAR TACHYCARDIA)-NS EPISODES, MOST RECENT (B)(6) 2023, 35 HIGH RATE-NS EPISODES, MOST RECENT ON (B)(6) 2023. SUSPECTED RV OVER-SENSING DURING RECORDED EPISODES. INAPPROPRIATE SHOCK WITH LEAD NOISE. R-WAVE MEASUREMENT 1.4 MV BELOW RANGE PER PREVIOUS LEAD TRENDS. 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
    2042858 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown