BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3040718 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00388
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0025-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING REVIEW OF THE DEVICE DATA CONFIRMED THE PRESENCE OF THE FAULT CODE, AND CONFIRMED THE DEVICE WAS DEPLETING FASTER THAN EXPECTED. TECHNICAL SERVICES RECOMMENDED DEVICE REPLACEMENT. AS OF TODAY, THE DEVICE REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS HOSPITALIZED FOR A NON-DEVICE RELATED ILLNESS. AT THE HOSPITAL, DEVICE INTERROGATION REVEALED A FAULT CODE 1003 HAD OCCURRED. THE DEVICE DATA WAS SAVED TO A DISK AND WAS SUBMITTED TO BOSTON SCIENTIFIC TECHNICAL SERVICES AND ENGINEERING FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143215 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1