BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3904513 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08750
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE BEING MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED STEADILY INCREASING RIGHT VENTRICULAR PACE IMPEDANCE MEASUREMENTS WHICH EVENTUALLY MEASURED GREATER THAN 2,000 OHMS. THERE WAS ALSO INCREASED PACING THRESHOLD MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE REASONS FOR THE CLINICAL OBSERVATIONS. THIS PRODUCT REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIEVED THAT THIS PATIENT HAS A LEFT VENTRICULAR ASSIST DEVICE AND IS ON THE TRANSPLANT LIST. NO FURTHER EVALUATION HAS BEEN PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384033 COGNIS IMPLANTABLE CHF PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR MISMATCH| 0283| 4549| P108