BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2052925 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03808
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    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 THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE. PRIOR TO THIS MOST RECENT INFORMATION, THIS LV LEAD WAS NOTED TO HAVE EXHIBITED OUT-OF-RANGE PACE IMPEDANCE WHILE TESTING OUTSIDE OF THE DEVICE POCKET AT IMPLANT. A NEW CONFIGURATION HAD RESOLVED THIS ISSUE PRIOR TO POCKET CLOSURE.

    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 74 YR Required Intervention 0185| 1298| N119| 4457| 4470| H170| 4543