BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVA QUAD XT

    MDR report key: 3931619 · Received July 14, 2014

    Report

    Report Number
    9614453-2014-01541
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 16, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. PRODUCT ID: UNK-COMP-LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY WITH CARDIAC ARREST AND PULSELESS ELECTRICAL ACTIVITY. IT WAS NOTED THAT AFTER THE ADMINISTRATION OF MEDICATION, CARDIOPULMONARY RESUSCITATION AND MECHANICAL VENTILATION THE PATIENT DIED. THE PATIENT WAS A PARTICIPANT OF THE (B)(6) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410236 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Death 6935, 5076 LEADS