BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2161554 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07179
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 16, 2011
    Report Date
    August 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RELAYED TO THE PHYSICIAN AND A FURTHER INVESTIGATION INTO THE MEASUREMENTS WAS TO BE PERFORMED. AT THIS TIME, THIS ICD REMAINS IMPLANTED AND IN SERVICE. ONCE ANY FURTHER INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. ALL SETSCREWS MOVED FREELY AND WITHOUT ISSUE. THE SEAL PLUGS AND CONNECTOR BLOCKS WERE INSPECTED AND NO ANOMALIES WERE FOUND. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE DEVICE MET ALL SPECIFICATIONS DURING TESTING

    Additional Manufacturer Narrative · 1

    DURING THE REVISION, THE TERMINAL PINS FOR THE PROXIMAL AND DISTAL DEFIBRILLATION COILS WERE REMOVED AND THEN REINSERTED INTO THE CRT-D HEADER. ONCE THE SETSCREWS WERE RE-ENGAGED, THE SHOCK IMPEDANCE MEASUREMENT IMPROVED, BUT THE SENSING AND PACING IMPEDANCE MEASUREMENTS DROPPED. FLUOROSCOPY WAS PERFORMED AND IT APPEARED THAT THE RV LEAD HAD MOVED. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED AND ALL MEASUREMENTS WERE WITHIN NORMAL PARAMETERS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DUE TO THE REVISION PROCEDURE. THE DEVICE AND RV LEAD REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. 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

    A TS CONSULTANT DISCUSSED DIFFERENT METHODS OF TROUBLESHOOTING TO DETERMINE A POSSIBLE ROOT CAUSE FOR THE OUT OF RANGE MEASUREMENTS. A PROCEDURE WAS BE SCHEDULED TO FURTHER INVESTIGATION THIS ISSUE. ONCE THE INVESTIGATION IS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ANOTHER REVISION WAS PERFORMED AND THE CRT-D AND RV LEAD WERE SUCCESSFULLY REPLACED. BOTH PRODUCTS WILL BE RETURNED FOR LABORATORY ANALYSIS. ONCE ANALYSIS IS COMPLETED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT A LEAD REVISION WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY AFTER THE IMPLANTATION OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE SHOCK IMPEDANCE MEASUREMENT WAS ABOVE 125 OHMS. IT IS BELIEVED THAT ONE OF THE DEFIBRILLATION TERMINAL PINS ON THE RIGHT VENTRICULAR (RV) LEAD WAS NOT FULLY INSERTED INTO THE DEVICE'S HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE ICD WAS RETURNED.

    Description of Event or Problem · 1

    DURING A NORMAL PATIENT FOLLOW UP, IT WAS DISCOVERED THAT THIS CRT-D HAD RECORDED ANOTHER OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. A REVIEW OF THE DAILY MEASUREMENTS FOUND THAT THE SHOCK IMPEDANCE MEASUREMENTS WERE FAIRLY STABLE IN MAY BUT THEN THEY STARTED FLUCTUATING AND ARE NOW ABOVE 125 OHMS. ALL OTHER LEAD MEASUREMENTS ARE WITHIN NORMAL RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other