BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1951401 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22751
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    June 20, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT REMAINS IN SERVICE, IT WILL NOT BE RETURNED FOR ANALYSIS AND BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE CLINICAL OBSERVATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A (B)(4) STUDY FORM REPORTING THAT THIS PATIENT WAS HOSPITALIZED DUE TO INFLAMMATION OF THE DEVICE POCKET WITHOUT SUPPURATION AND WOUND OPENING. SIX DAYS LATER, A QUIRURGYCAL PROCEDURE WAS PERFORMED, ENLARGING THE SIZE OF THE POCKET. CULTURE FLUID WAS EXTRACTED AND NO FURTHER COMPLICATIONS WERE FOUND. THE CASE WAS CLASSIFIED AS EROSION. THE DEVICE WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE.

    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 Hospitalization| R