BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1771412 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12555
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED SUGGEST THAT THE EPICARDIAL DRAIN HAS BEEN REMOVED THAT THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO DAYS AFTER THE IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CDT-D) A CARDIAC TAMPONADE WAS NOTED. AN EPICARDIAL DRAIN WAS USED TO DRAIN FLUID. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE TAMPONADE. THE PATIENT IS STABLE BUT REMAINS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1