BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2171274 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-12085
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 5, 2011
    Report Date
    November 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THAT THE SHOCK IMPEDANCE MEASUREMENTS HAD BEEN STABLE IN THE 40'S TO LOW 50'S AND THEN INCREASED TO GREATER THAN 125 OHMS. THE CONSULTANT SUGGESTED SOME FURTHER TESTING TO BE PERFORMED TO VERIFY THE INTEGRITY OF THE SYSTEM. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED IN (B)(6) 2011 STATING THIS PATIENT HAD 60 BURSTS OF ANTI-TACHYCARDIA PACING (ATP). THE CALLER WAS INQUIRING IF THE ATP COULD CONVERT SUPRAVENTRICULAR TACHYCARDIA (SVT). A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT STATED THAT ATP HAS BEEN KNOWN TO CONVERT SVT. THE CONSULTANT STATED THAT THERAPY DELIVERY CANNOT BE GUARANTEED WITH THE CURRENT IMPEDANCE MEASUREMENTS AND PROGRAMMING. THE PATIENT HAD BEEN RELUCTANT TO HAVE ADDITIONAL THERAPY PREVIOUSLY. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS SYSTEM DUE TO A HIGH SHOCK LEAD IMPEDANCE. THE CALLER STATED THAT THE PROCEDURE TO IMPLANT THIS SYSTEM WAS DIFFICULT AND THEY COULD NOT OBTAIN ACCEPTABLE DEFIBRILLATION TESTING (DFTS) WITH DUAL COIL LEAD AND COMPETITIVE LEAD. THE PATIENT IS NON-COMPLIANT AND HAS REFUSED TO WHERE A LIFE VEST BECAUSE THERE IS NOT AN ACCEPTABLE SAFETY MARGIN. PATIENT HAS ALSO REFUSED FURTHER DFT TESTING NOW THAT AMINODARONE HAS BEEN DISCONTINUED. THE PATIENT AND FAMILY ARE AWARE THAT THE DEVICE MAY NOT BE ABLE TO RESCUE HIM IN THE EVENT OF AN ARRHYTHMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4554| N119| 0180| 7120| (B)(4)| 4135