BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043077 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01548
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 NON-BSC LEFT VENTRICULAR (LV) LEAD DISPLAYED INCREASING PACING IMPEDANCE MEASUREMENTS, ULTIMATELY REACHING GREATER THAN 2,000 OHMS. PACING THRESHOLD MEASUREMENTS HAD DECREASED FROM 2.6V TO 1.1V. THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) WAS ELECTING TO CONTINUE TO MONITOR. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146012 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR T135| N119| MISMATCH| 0158