BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 17533224 · Received August 12, 2023

    Report

    Report Number
    MW5140128
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    August 10, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NIK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 07/03/2012 FROM SALES REP. DIAPHRAGMATIC STIM. CONSIDER ALSO DIALING DOWN LV OUTPUTS TO AVOID STIM IF TAILBACK OCCURS. THE PHYSICIAN WAS DR (B)(6). UNKNOWN HOSPITAL. 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
    727934 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK ST. JUDE MEDICAL 1056T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown