BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3041173 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01260
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    June 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

    ACCORDING TO AVAILALBE INFORMATION, THIS SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE AND RIGHT VENTRICULAR LEAD REMAIN IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Description of Event or Problem · 1

    A FOLLOW UP VISIT WAS PERFORMED. NO NOISE EPISODES WERE OBSERVED DURING POCKET MANIPULATION, ISOMETRIC AND ARM MOVEMENTS. SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL WITH THE LEFT ARM IN NORMAL POSITION AND HIGH WHEN THE LEFT ARM WAS POSITIONED ABOVE THE HEAD. SEVERAL MANEUVERS REVEALED SIMILAR RESULTS. IT WAS THOUGHT THERE WAS AN ISSUE AT THE DEVICE POCKET SITE CAUSING AN INTERMITTENT CONTACT WITH THE DEVICE. ALTHOUGH LEAD INTEGRITY TESTING WAS RECOMMENDED, DUE TO THE PATIENT¿S CONDITION, A DECISION WAS MADE TO FURTHER MONITOR THIS SYSTEM WITH REMOTE MONITORING AND FREQUENT FOLLOW UP VISITS. ALL RV LEAD MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, A SAVE TO DISK FROM THIS DEVICE WAS PROVIDED TO TECHNICAL SERVICES FOR THEIR REVIEW. SEVERAL HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS HAVE BEEN RECORDED AND THE RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS HAVE DECREASED DURING THE PAST FEW MONTHS. THE ARRHYTHMIA LOGBOOK REVEALED NUMEROUS VENTRICULAR EPISODES HAD OCCURRED AND THERE IS NOISE ON THE RIGHT VENTRICULAR AND SHOCK CHANNELS. FURTHER SYSTEM INTEGRITY INCLUDING A HIGH RESOLUTION X-RAY OF THE HEADER WAS RECOMMENDED TO VERIFY WHETHER THERE MAY BE A SUB OPTIMAL CONNECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS REPROGRAMMED AND A LEAD REVISION IS INTENDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A FURTHER OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT HAD BEEN RECORDED, HOWEVER THERE HAD BEEN NO ALERT, HOWEVER TS REVIEWED THE DATA AND DETERMINED THE OUT OF RANGE MEASUREMENT HAD OCCURRED PRIOR TO THE RESET OF PREVIOUS OUT OF RANGE MEASUREMENT. FURTHER REVIEW OF THE DATA DETERMINED THAT THE SHOCK IMPEDANCE MEASUREMENT REVEALED NOISE DURING DEVICE PACING. FURTHER LEAD INTEGRITY INVESTIGATION WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143480 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1