BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1952623 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23639
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE DEVICE AND LEAD WILL NOT BE RETURNED THUS NO ANALYSIS WILL BE COMPLETED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS PI WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS POST OPERATIVE CHECKS OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH OUT OF RANGE PACING IMPEDANCES. THE RV LEAD WAS DISCONNECTED AND RECONNECTED BACK TO THE DEVICE WHICH SHOWED NORMAL VALUES. A CONNECTION PROBLEM WAS SUSPECTED. THE DEVICE AND LEAD REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE 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