BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2170794 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10648
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    December 15, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEADS REMAIN IN SERVICE. THE PHYSICIAN WILL CONTINUE TO MONITOR THE SYSTEM AND PATIENT. 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

    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, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED ALMOST FIVE YEARS LATER FOR REPORTED NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, THE LEFT VENTRICULAR (LV) LEAD AND ANOTHER MANUFACTURES RIGHT VENTRICULAR (RV) LEAD DISPLAYED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. UPON INTERROGATION, NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS WERE STORED WHICH DISPLAYED NOISE ON THE RV CHANNEL. THE RV LEAD IMPEDANCE WAS FLUCTUATING HOWEVER THE HIGH MEASUREMENTS COULD NOT BE REPRODUCED WITH TESTING. IT WAS REPORTED THAT A LEAD REVISION PROCEDURE WILL NOT BE PERFORMED AT THIS TIME AS THE LV LEAD LOOKED FINE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)