BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1852079 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-17939
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED SECONDARY DUE TO PATIENT INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION. A NEW DEVICE SYSTEM MAY BE IMPLANTED ONCE THE PATIENT IS CLEARED BY THE PHYSICIAN. THE LEADS WEER DISCARDED AND NOT RETURNED TO THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4517| 0157| N118