BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1951462 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22887
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 9, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 FROM THE LOCAL REPRESENTATIVE THAT THIS DEVICE AND LEAD SYSTEM WERE SUCCESSFULLY EXPLANTED APPROXIMATELY 1-2 WEEKS AGO DUE TO INFECTION. A COMPETITOR LOCAL REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE AND IT WAS NOT KNOWN IF THE EXTRACTED SYSTEM WILL BE RETURNED OR WAS DISPOSED OF BY THE HOSPITAL STAFF. SUBSEQUENTLY, A REPLACEMENT DEVICE AND LEAD SYSTEM WERE SUCCESSFULLY IMPLANTED.

    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 75 YR Hospitalization| L| R MISMATCH| 0185| 4470| 4543| N119| H170