BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3771408 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09093
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    November 17, 2011
    Report Date
    February 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN THRESHOLD MEASUREMENTS. AN INCREASE IN PACING IMPEDANCE MEASUREMENTS WAS ALSO OBSERVED INCLUDING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. ADDITIONALLY, LOW LV INTRINSIC AMPLITUDES WERE OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING HIGH PACING IMPEDANCE MEASUREMENTS AND HIGH THRESHOLD MEASUREMENTS CONTINUED TO BE OBSERVED. THE LV LEAD WAS PROGRAMMED OFF AND WILL BE FURTHER EVALUATED WHEN THE PATIENT'S DEVICE NEEDS REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT IMPLANTED WITH THE LV EXPERIENCED WORSENING HEART FAILURE. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CAUSE OF THE HIGH PACING IMPEDANCE MEASUREMENTS WAS DUE TO A FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249199 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 4470| N119| 0185| H177| 4543