BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4132526 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14907
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    January 12, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0025-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ALL AVAILABLE INFORMATION SUGGESTS THE DEVICE REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND REPLACED WITH A NON BOSTON SCIENTIFIC DEVICE. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY FOR WHICH DEVICE REPLACEMENT IS RECOMMENDED. IT WAS ALSO REPORTED THAT THE IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD IS HIGH OUT OF RANGE. THE TWO ISSUES ARE NOT THOUGHT TO BE RELATED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611335 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R 4592| 0185| N119| 4543| 4470