BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 17530284 · Received August 12, 2023

    Report

    Report Number
    MW5137204
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    January 12, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NIK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS DEVICE WA IMPLANTED ON (B)(6) 2011 AND WAS EXPLANTED ON (B)(6) 2016 DUE TO RECALL. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) IN (B)(6), KY. NO OTHER INFORMATION IS AVAILABLE. 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
    1049417 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK ST. JUDE MEDICAL CD3231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown