BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2170018 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09418
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DURING LABORATORY ANALYSIS IT WAS DETERMINED THAT THIS PRODUCT REVERTED TO SAFETY CORE DURING THE EXPLANT PROCEDURE. MICROSCOPIC VISUAL INSPECTION OF THE HEADER FOUND IT TO BE COMPLETELY INTACT AND THE LEADS WERE FULLY INSERTED INTO THE HEADER. A REVIEW OF THE MEMORY LOG FOUND THAT THE DEVICE RECORDED 4 FAULTS ON (B)(6) 2011. IT IS KNOWN THAT IF ELECTROCAUTERY IS BEING APPLIED NEAR THE DEVICE SITE DURING SURGERY THIS MAY CAUSE THE OSCILLATOR TO TEMPORARILY NOT FUNCTION PROPERLY WHICH IS KNOWN TO CAUSE A SYSTEM FAULT WHICH WILL CAUSE THE DEVICE TO GO INTO SAFETY CORE. IT WAS VERIFIED THAT THE DEVICE WAS ABLE TO OPERATE WITHIN SAFETY MODE. THE DEVICE WAS PUT THROUGH A SERIES OF AUTOMATED TESTS, WHICH VERIFIED THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE. NO FURTHER ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED FOR EROSION. THERE WERE NO ADDITIONAL FIELD ALLEGATIONS REPORTED AGAINST THIS PRODUCT. THIS REPORT WAS CREATED DUE TO LABORATORY FINDINGS.

    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 71 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)