BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1852756 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14480
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INTERVENTION, THE PHYSICIAN ELECTED TO REPOSITION THE DEVICE. THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. IF NEW DETAILS ARE RECEIVED, THIS EVENT WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT APPROXIMATELY 1.5 MONTHS POST IMPLANT, THE PATIENT WITH THIS DEVICE PRESENTED WITH INFECTION. NO ALLEGATIONS AGAINST THE BSC PRODUCT AS A CAUSATIVE FACTOR.

    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 50 YR Required Intervention N119| 5076| 7279| 6947| 4194