BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 6508336 · Received April 20, 2017

    Report

    Report Number
    2124215-2017-01109
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    September 1, 2016
    Report Date
    October 12, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    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. 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. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. 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 DEVICE WAS EXPLANTED AND WILL BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    AT THIS TIME NO ACTION HAS TAKEN PLACE WHEN IT COMES TO THIS CASE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS NOTED WHEN IT COMES TO THIS DEVICE. THE NOISE TRIGGERED A NON SUSTAINED VENTRICULAR EPISODE WHICH WAS NOT TREATED. SENSITIVITY WAS INCREASE ON BOTH CHANNELS. NOISE WAS NOTED ON BOTH LEADS A POSSIBLE CONNECTION ISSUE WAS SUSPECTED. THE SENSING AND IMPEDANCE MEASUREMENTS APPEARED STABLE. A REQUEST FOR ANALYSIS BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS NEEDED. TS REVIEWED THE DATA DISK SOME LOW INTRINSIC RV AMPLITUDES WERE NOTED. TS DISCUSSED ATTEMPTING TO RECREATE THE NOISE AND FOCUS ON THE DEVICE HEADER. A SAVE ALL TO DISK WAS REQUEST FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO REPORTED OVERSENSING OR ASYSTOLE FOR GREATER THEN TWO SECONDS. FURTHER REVIEW BY TS NOTED THAT ALL EVENTS REVIEWED WERE NON SUSTAINED THUS THEY ARE ALL LOW PRIORITY AND THERE WAS NO GUARANTEE AND OF THEM WILL HAVE AN ELECTROCARDIOGRAM FOR REVIEW STILL AVAILABLE. TS DISCUSSED A POSSIBLE DEVICE HEADER COULD HAVE A WEAKEN BOND AND LEAD TO ISSUES, ALSO A POTENTIAL INTERMITTENT OUTER INSULATION ISSUES OR EVEN SEAL PLUG ISSUES THAT COULD ALLOW FOR UNIPOLAR SENSING VECTORS ALLOW THE DEVICE TO SEE PECTORAL MUSCLE NOISE BUT NOT LEAD TO ANY CHANGES IN IMPEDANCE AS THE CONDUCTORS ARE INTACT. MORE TESTING WAS DISCUSSED BY TS TO DETERMINE THE ROOT CAUSE OF THIS CASE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THE SENSITIVITY WAS INCREASED. FURTHER FEEDBACK WAS REQUEST BY TS. TS NOTED THAT THE DATA SENT IN DID NOT CONTAIN EPISODE FILES THUS NO FURTHER DISCUSSION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BY TS NOTED THAT NOISE WAS SEEN ON THE ATRIAL AND VENTRICULAR LEAD. THE VALUES OF THE LEAD APPEAR NORMAL WITH DEFLECTIONS ON THE ATRIAL ELECTROCARDIOGRAM BEING LARGER THAN ON THE RIGHT VENTRICULAR ELECTROCARDIOGRAM. TS DISCUSSED POSSIBLE ROOT CAUSE OF THE NOTED OBSERVATIONS AND ALSO DISCUSSED POSSIBLY DOING AN INVASIVE PROCEDURE TO CORRECT THE PROBLEM AND DETERMINE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288611 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R P107