BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3050047 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04260
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    June 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED FOLLOWING THE PATEINT'S DEATH. THE DEVICE WAS RETURNED FOR ANALYSIS. THERE WERE NO DEVICE ALLEGATIONS RELATING TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE INTERROGATION, THE CLINICIAN NOTED ONE STORED VENTRICULAR EPISODE WITH NOISE ON RIGHT VENTRICULAR (RV) AND SHOCK CHANNELS. PACING WAS INHIBITED FOR ABOUT FOUR SECONDS TO AN ESCAPE RATE OF AROUND 30 BPM. IT WAS NOTED THAT THE PATIENT WAS ASYMPTOMATIC AND WAS UNAWARE OF WHAT HE WAS DOING AT THE TIME OF THE EPISODE. ISOMETRICS WERE NEGATIVE FOR RV NOISE, HOWEVER THERE WAS NOISE ON THE SHOCK CHANNEL. THE SENSITIVITY WAS PROGRAMMED TO 0.8MV AND THEY WILL CONTINUE NORMAL THREE MONTH FOLLOW-UPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149362 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 4538| 4087| N119| 0158| 1861| H170