BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3053587 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05584
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 2, 2012
    Report Date
    March 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE INTERROGATION WAS PERFORMED AND THE SHOCK IMPEDANCE MEASUREMENTS WERE SLIGHTLY ELEVATED. NO CORRECTIVE ACTION WAS NECESSARY AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS RECEIVED FROM THIS SYSTEM DUE TO A HIGH SHOCK LEAD IMPEDANCE MEASUREMENTS. THIS PATIENT'S SYSTEM CONSISTS OF A BOSTON SCIENTIFIC DEVICE AND A COMPETITIVE DEFIBRILLATION LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155736 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR N119| 4592| MISMATCH