BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2053619 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04295
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    December 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    MICROSCOPIC VISUAL INSPECTION FOUND THAT THE HEADER WAS COMPLETELY INTACT AND THERE WAS NO BODY FLUID IN THE RV PORT. FURTHER INVESTIGATION DETERMINED THAT THE RV LEAD MAY NOT HAVE BEEN FULLY INSERTED INTO THE HEADER. THE DEVICE WAS PUT THROUGH AND PASSED PIN GAUGE TESTING (RA, RV, LV, DF+,DF- PORTS) AND OPERATIONAL DIAGNOSTIC TESTING. IT WAS CONCLUDED THAT THE RV LEAD MAY NOT HAVE BEEN INSERTED PROPERLY AND AFTER SEVERAL MONTHS OF IMPLANT, THE RV LEAD LOST CONTACT CAUSING THE HIGH RV LEAD IMPEDANCE. THE DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    UPON RETURN, THE DEVICE WILL UNDERGO LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT HAD BEEN SCHEDULED FOR A REVISION PROCEDURE FOLLOWING A SCHEDULED IN-CLINIC FOLLOW-UP. BOTH THE RV AND LV PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS ASSOCIATED WITH LOSS OF CAPTURE. TS WAS INFORMED THAT WHEN THE LV CONFIGURATION WAS REPROGRAMMED TO LV (TIP) TO CAN, THE IMPEDANCE MEASUREMENT WAS NORMAL BUT THE RV MEASUREMENT WAS STILL OUT-OF-RANGE (OOR). THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND THE POCKET WAS OPENED. THE LEADS WERE TESTED WITH A PACING SYSTEM ANALYZER (PSA) AND BOTH OF THE LEADS IMPEDANCE MEASUREMENTS WERE NORMAL. THE PACING THRESHOLDS IN THE RV AND LV WERE 1.9 VOLTS AT 0.4 MS AND 4.1 VOLTS AT 1.0 MS RESPECTIVELY. NO ISSUES WERE IDENTIFIED WITH DEVICE SENSING. THE PHYSICIAN COMMENTED THAT THE RV DISTAL PORT WAS DISCOLORED. HOWEVER, WHEN THE LEADS WERE RECONNECTED, THE PACING IMPEDANCE MEASUREMENTS WERE NORMAL. BASED ON AN ESTIMATED REMAINING LONGEVITY CALCULATION, THE PHYSICIAN ELECTED TO REPLACE THE CHRONIC DEVICE. BOTH THE RV AND LV LEADS REMAINED INS-SERVICE. WHEN THE CHRONIC LEADS WERE CONNECTED TO THE REPLACEMENT DEVICE, NO ISSUE WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM EXHIBITED INCREASED RIGHT VENTRICULAR (RV) PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. UPON REVIEW, ONE EPISODE HAD NOISE LASTING 1.5 SECONDS, RESULTING IN APPROPRIATE STORAGE OF NON-SUSTAINED VENTRICULAR TACHYCARDIA. TECHNICAL SERVICES DISCUSSED EVALUATION RECOMMENDATIONS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    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 80 YR H170| N119| 4538| 0158| 4470