BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2153568 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06887
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 10, 2011
    Report Date
    December 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    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 THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A RED RASH ON THE IMPLANT POCKET APPROXIMATELY TWO WEEKS POST DEVICE IMPLANT. UPON FURTHER EVALUATION OF THE POCKET AREA, IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. A REVISION PROCEDURE WAS PERFORMED. THE DEVICE AND LEADS WERE CLEANED AND RE-IMPLANTED SUBPECTORAL. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT APPROXIMATELY EIGHT MONTHS LATER DUE TO INFECTION. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL 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 N119

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 4479| N119| H177| 4542| 0158