BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1852672 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14401
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC CRM. SHOULD ADDITIONAL INFORMATION BECOME AVAILALBE, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ENTIRE PACING SYSTEM WAS REMOVED DUE TO AN INFECTION. THE PATIENT HAD DEVELOPED AN INFECTION IN THE SUTURE SLEEVE THAT ENDED UP INFECTING THE POCKET AND THE WHOLE SYSTEM. UPON EXTRACTION OF THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD, IT WAS OBSERVED THAT THE HELIX COULD NOT BE RETRACTED. THE LEAD WAS REMOVED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention