BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVA QUAD XT

    MDR report key: 3920030 · Received July 8, 2014

    Report

    Report Number
    9614453-2014-01531
    Event Type
    Death
    Date Received
    July 8, 2014
    Date of Event
    September 30, 2013
    Report Date
    June 13, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DECEASED AND DIED DUE TO VENTRICULAR FIBRILLATION. IT WAS NOTED THAT EMERGENCY MEDICAL SERVICE WAS CALLED AND RESUSCITATION WAS INITIATED WITH THE DEVICE DELIVERING MULTIPLE SHOCKS. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY. THE ADVERSE EVENT ADJUDICATION COMMITTEE ADJUDICATED THE EVENT AS "UNKNOWN" IF RELATED TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATION (ICD) SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396236 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Death 4076, 6947, 4298 LEADS