BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2052883 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03734
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. 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 WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FLUCTUATING IMPEDANCE MEASUREMENTS FROM 500 OHMS TO 1300 OHMS ALONG WITH LOSS OF CAPTURE (LOC) TEN MONTHS PRIOR. GOOD CAPTURE WAS NOTED AROUND 500 OHMS AND NO CAPTURE AROUND 1300 OHMS. EIGHT MONTHS LATER IT WAS REPORTED THAT CONTINUED FLUCTUATING IMPEDANCE MEASUREMENTS, NOISE AND OVERSENSING WERE OBSERVED, NO ASYSTOLE WAS REPORTED. A LEAD TO DEVICE CONNECTION ISSUE WAS SUSPECTED HOWEVER NO INTERVENTION WAS PERFORMED AND SENSING WAS PROPERLY ADJUSTED. SIX WEEKS LATER, A REVISION PROCEDURE WAS PERFORMED WERE THIS RV LEAD WAS EXAMINED IN THE DEVICE PORT AND WHEN THE PHYSICIAN PERFORMED THE TUG TEST, THE LEAD REMAINED IN PLACE. THE RV LEAD WAS THEN TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) AND A NORMAL MEASUREMENT OF 600 OHMS WAS OBSERVED. DEFIBRILLATORY THRESHOLD TESTING WAS PERFORMED WITH THE GUIDEWIRE LEFT IN THE LEAD LUMEN AS NOT TO LOSE VENOUS ACCESS. THE EXISTING RV LEAD WAS PLACED BACK IN SERVICE ALONG WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 44 YR Required Intervention MISMATCH| N119| 0185