BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2052591 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03510
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A TS REPRESENTATIVE REVIEWED THE INFORMATION AND DISCUSSED THAT THE SIGNAL OBSERVED ON THE ELECTROCARDIOGRAM WAS DUE TO AUTO LEAD DETECT (ALD) DUE TO THE DEVICE MEASURING THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE EVERY TWO SECONDS DUE TO IT BEING ABOVE 2,000 OHMS. THIS IS A NORMAL DEVICE FUNCTION WHEN IT DETECTS THE OUT OF RANGE MEASUREMENT. THE ALD SIGNAL IS OBSERVED AS AN ARTIFACT ON THE ELECTROCARDIOGRAM. ONCE AN IN-RANGE PACING IMPEDANCE MEASUREMENT VALUE IS OBTAINED, THE ALD STOPS AND WILL NOT START AGAIN. IT WAS DISCUSSED THAT THE RV LEAD HAD AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT WHICH WAS STOPPED ONCE THE LV LEAD HAD BEEN TEMPORARILY CONNECTED TO THE RV PORT. IT WAS ALSO REPORTED THAT THE PACING IMPEDANCE MEASUREMENT FOR THIS RV LEAD HAD BEEN ABOVE 2,000 OHMS DURING THE PROCEDURE. THE TS REPRESENTATIVE DISCUSSED SEVERAL TROUBLESHOOTING METHODS TO DETERMINE IF THE OUT OF RANGE MEASUREMENT WAS DUE TO A LEAD OR CONNECTION ISSUE. AT THIS TIME, THIS DEVICE AND LEAD REMAINS IMPLANTED AND 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING DEFIBRILLATION TESTING OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DURING THE IMPLANTATION PROCEDURE, A SIGNAL WAS OBSERVED ON THE VENTRICULAR CHANNEL THAT WAS OVERSENSED BY THE DEVICE. ALL EXTERNAL ELECTRICAL EQUIPMENT WAS TURNED OFF AND THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS DISCONNECTED FROM THE DEVICE AND CONNECTED TO THE PACING SYSTEM ANALYZER (PSA). THE SIGNAL WAS THEN NO LONGER OBSERVED. WHEN THE LEAD WAS RECONNECTED TO THE CRT-D, THE SIGNAL WAS AGAIN OBSERVED ON THE ELECTROGRAM. SEVERAL OTHER METHODS OF TROUBLESHOOTING WERE PERFORMED BUT THE SIGNAL WAS STILL VISIBLE. BOTH THE IS-1 PORTION OF THE DEFIBRILLATION LEAD AND THE LEFT VENTRICULAR (LV) LEAD WERE DISCONNECTED AND THEN RECONNECTED IN THE OPPOSING HEADER PORT. THE SIGNAL WAS THEN NO LONGER OBSERVED ON THE ELECTROGRAM. THE IS-1 AND LV LEAD WERE THEN RECONNECTED BACK TO THE CORRECT PORTS AND THE SIGNAL WAS STILL NO LONGER PRESENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A PRINTOUT OF THE SIGNAL WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1