BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1863682 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15866
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    June 28, 2010
    Report Date
    December 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST HAS BEEN MADE FOR THE DEVICE TO BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. ADDITIONAL INSPECTION OF THE ATRIAL LEAD BARREL SHOWED SEAL RING MARKS CONSISTENT WITH A LEAD THAT WAS NOT FULLY INSERTED. ALL SETSCREWS WERE TESTED AND FOUND TO BE FUNCTIONING NORMALLY. THE ATRIAL AND RIGHT VENTRICULAR PORT SPRING CONNECTORS WERE EVALUATED WITH GAUGE PINS AND CONFIRMED TO MEET DESIGN SPECIFICATIONS. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED, BUT IT WAS LIKELY THAT THE ISSUES WITH THE ATRIAL LEAD SEEN DURING THE REVISION PROCEDURE WERE CAUSED BY THE ATRIAL LEAD TERMINAL PIN NOT BEING FULLY INSERTED INTO THE DEVICE PORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED RIGHT VENTRICULAR (RV) PACE IMPEDANCE GREATER THAN 2000 OHMS, DECREASED R-WAVE SENSING AND A LOSS OF RV CAPTURE AT MAXIMUM OUTPUTS. NOISE AND OVERSENSING WERE ALSO NOTED. THERE WERE A FEW EPISODES ON NON-SUSTAINED VENTRICULAR TACHYCARDIA DUE TO THE NOISE BUT NO THERAPY WAS DELIVERED. THERE WAS NO EVIDENCE OF PACING INHIBITION. IT WAS DETERMINED THAT THE RATE/SENSE PORTION OF THE RV LEAD WAS FRACTURED. ALL BRADYCARDIA AND TACHYCARDIA THERAPY WAS DISABLED UNTIL A REVISION COULD BE PERFORMED. DURING THE RV LEAD REVISION, IT WAS NOTED THAT RIGHT ATRIAL (RA) IMPEDANCE WAS GREATER THAN 2000 OHMS, THERE WAS INTERMITTENT LOSS OF CAPTURE AND SENSING ISSUES WHEN THE CHRONIC RA LEAD WAS INSERTED INTO THE EXISTING DEVICE. THESE OBSERVATIONS WERE NOT SEEN WHEN THE LEAD WAS CONNECTED TO THE PACING SYSTEM ANALYZER. DESPITE FURTHER EVALUATION, THE PHYSICIAN WAS UNABLE TO DETERMINE WHETHER THERE WAS A CONNECTION/SETSCREW ISSUE OR A LEAD ISSUE. THE PHYSICIAN ELECTED TO REPLACE BOTH THE DEVICE AND THE RA LEAD. A NEW BOSTON SCIENTIFIC DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4525| H135| 0185| 4470| N118