BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2161214 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07303
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    January 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED DUE TO RIGHT VENTRICULAR LEAD HIGH SHOCK IMPEDANCE MEASUREMENTS. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN. A DECISION WILL BE MADE REGARDING THIS ISSUE IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. REPORTEDLY, THE IMPEDANCE MEASUREMENTS HAVE BEEN KNOWN TO BE OUT OF RANGE AND A DECISION WAS MADE TO FURTHER MONITOR WITH NO INTERVENTION. IT WAS THOUGHT DEFIBRILLATION THRESHOLD (DFT) TESTING MAY HAVE BEEN PERFORMED OR THE LEAD HAS BEEN OTHERWISE VERIFIED AS BEING FUNCTIONAL. CURRENTLY, THE LEAD IMPEDANCE VARIES AND THE HOSPITAL AND PHYSICIAN ARE AWARE OF THIS ISSUE. ADDITIONAL INFORMATION WAS RECEIVED. REPORTEDLY, THE IMPEDANCE MEASUREMENTS HAVE BEEN KNOWN TO BE OUT OF RANGE AND A DECISION WAS MADE TO FURTHER MONITOR WITH NO INTERVENTION. IT WAS THOUGHT DEFIBRILLATION THRESHOLD (DFT) TESTING MAY HAVE BEEN PERFORMED OR THE LEAD HAS BEEN OTHERWISE VERIFIED AS BEING FUNCTIONAL. CURRENTLY, THE LEAD IMPEDANCE VARIES AND THE HOSPITAL AND PHYSICIAN ARE AWARE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention