BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1946110 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20150
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D REMAINS IN SERVICE, SO WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED SYNCOPE. AFTER THE PHYSICIAN IMPLANTED AND TESTED ASSOCIATED RIGHT VENTRICULAR (RV) LEAD, THIS PATIENT FELT SUDDEN SYNCOPE. THERE WAS NO LOSS OF STRENGTH. AFTER ABOUT 25 MINUTES THAT PATIENT PARTIALLY RECOVERED. A NEUROLOGIST WAS THEN CONSULTED, AND THERE WAS REPORT OF NO APHASIA OR ABNORMALITIES. AFTER SOME TIME THE PATIENT RECOVERED FULLY. THE PHYSICIAN ELECTED TO STOP THE IMPLANT PROCEDURE. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1