BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 4132076 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14586
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    December 1, 2012
    Report Date
    August 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND COMPETITOR RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASED IMPEDANCE MEASUREMENTS AND INCREASED THRESHOLD MEASUREMENTS. AS A RESULT, THE RV LEAD WAS EXPLANTED AND REPLACED. MORE THAN A YEAR LATER, THE RV LEAD EXHIBITED DECREASED IMPEDANCE MEASUREMENTS AROUND 200 OHMS AND INCREASED THRESHOLD MEASUREMENTS. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD WAS NOT CAPTURING WITH HIGH THRESHOLD AND IMPEDANCE MEASUREMENTS. THIS PATIENT IS PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610514 COGNIS IMPLANTABLE CHF PULSE GENERATOR DTB GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1