BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1860475 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15169
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEADS HAVE BEEN RETAINED BY THE HOSPITAL'S PATHOLOGY DEPARTMENT, AND AVAILABLE INFORMATION SUGGESTS THAT THESE PRODUCTS WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR PATIENT'S ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT'S EXPLANTED LEADS INCLUDE A TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD, A TRANSVENOUS LEFT VENTRICULAR (LV) LEAD, AND AN OEM MANUFACTURED RIGHT ATRIAL (RA) LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R 4135| 4480| 0184| N119| 4542| 4513| 0157| H179| 4555| H220| H229| 0148