BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 17527411 · Received August 12, 2023

    Report

    Report Number
    MW5134343
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    June 12, 2016
    Report Date
    June 1, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NIK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2016 21:00:20 *LVL TO RVCOIL LEAD IMPEDANCE >3000 OHMS. (B)(4). 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
    2218471 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK ST. JUDE MEDICAL 1458Q75

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown