BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1850106 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-14819
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A LOOSE HEADER. THE WIRES HAD EVIDENCE OF CYCLICAL FATIGUE FRACTURES AS WELL AS DUCTILE FRACTURES. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE DETECTED HIGH, OUT OF RANGE SHOCK IMPEDANCES. AN INVASIVE PROCEDURE WAS PERFORMED AND IDENTIFIED THAT THE DEVICE'S HEADER WAS LOOSE. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

    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 68 YR Required Intervention N119| 0185| 4543| 4470| 4592