BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2060162 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05893
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    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 THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO A POCKET INFECTION. THE RIGHT ATRIAL, AND RIGHT AND LEFT VENTRICULAR LEADS REMAIN IN-SERVICE AS THERE WAS NO EVIDENT VEGETATION ON THE LEADS THEMSELVES. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN THE POSSESSION OF THE HOSPITAL.

    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 82 YR Required Intervention 4017| 4549| 1283| N119| H170| 4543| 4285| 1174| 0184