BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1864040 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15798
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 5, 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 ICD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC CRM 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A LOSS OF CAPTURE, AND OVERSENSING. IT WAS NOTED, HOWEVER, THAT THIS WAS DUE TO LEFT VENTRICULAR (LV) LEAD DISLODGMENT. THE PHYSICIAN ELECTED TO REPLACED THE LV LEAD AND REPROGRAM THE CRT-D. THE LV LEAD WAS A COMPETITOR'S LEAD. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT DEVELOPED PNEUMOTHORAX. THIS PATIENT EXPERIENCED FATIGUE / TIREDNESS; DYSPNEA / BREATHLESSNESS; CHEST PAIN / ANGINA. 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 P107

    Patients

    Seq Age Sex Outcome Treatment
    1