BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3223566 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10250
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 4, 2013
    Report Date
    October 28, 2013
    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE RV LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    LABORATORY ANALYSIS OF THE LEAD CONFIRMED A LEAD INSULATION DAMAGE WHICH CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LOW PACING IMPEDANCE WAS OBSERVED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION INDICATED THAT THE ABNORMAL IMPEDANCE MEASUREMENTS WERE SUSPECTED TO BE DUE TO INSULATION ISSUES WITH THE LEAD. MORE FREQUENT PATIENT MONITORING WAS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324211 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R