BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 18040830 · Received October 30, 2023

    Report

    Report Number
    MW5147529
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FIFTEEN (15) VT-NS EPISODES, MOST RECENT (B)(6) 2023; 35 HIGH RATE-NS EPISODES, MOST RECENT ON 03 SEP 2023. SUSPECTED RV OVER-SENSING DURING RECORDED EPISODES ALERT: RV LEAD INTEGRITY WARNING ON (B)(6) 2023 (2 OR MORE CRITERIA MET). 35 REVIEW HIGH RATE-NS EPISODES, SENSING INTEGRITY COUNTER (592 SHORT V-V INTERVALS) AND RV LEAD IMPEDANCE 3000 OHMS 592 SHORT V-V INTERVALS. RV LEAD IMPEDANCE > 300 OHMS RESOLUTION CODE: ANSWERED QUESTION OR PROVIDED EDUCATION/DO. 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
    2100852 RV LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown