BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LV LEAD

    MDR report key: 17510535 · Received August 10, 2023

    Report

    Report Number
    MW5123015
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    Q: LV IMPEDANCE >3000 D: CALLER PROVIDED PATIENT SERIAL NUMBER. R: LOOKED UP PATIENT IN CARELINK. CONFIRMED ALERT: LEFT VENTRICULAR LV RING TO RV COIL LEAD IMPEDANCE WARNING ON (B)(6) 2023. REVIEWED CURRENT EGM DISCUSSED TAKING SERIAL IMPEDANCES AND THRESHOLDS IN CURRENT CONFIGURATION, AND OTHER LV POLARITIES: LVT TORVC; LVT TO LVR; LVR TO LVT. 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
    1084161 LV LEAD DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK BOSTON SCIENTIFIC CORPORATION 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown