BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4132119 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17206
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 19, 2014
    Report Date
    October 9, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

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

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR THE RETURN OF THE PRODUCT HAS BEEN MADE.

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE EMERGENCY ROOM WHERE NOISE WAS NOTED TO BE PRESENT ON THE RV CHANNEL. THE NOISE WAS OVERSENSED AND LED TO AN INAPPROPRIATE SHOCK AS WELL AS PACING INHIBITION WITH ASSOCIATED DIZZINESS. THE NOISE WAS ABLE TO BE REPRODUCED WITH ARM MOVEMENTS. AN INCREASE IN RV PACING THRESHOLD WAS ALSO NOTED. AN INSULATION BREACH WAS SUSPECTED. AN X-RAY WAS PERFORMED THAT SHOWED THE PATIENT'S LEADS WERE CLOSE TOGETHER. THE DEVICE WAS PROGRAMMED TO DOO AT 75 WITH ELECTROCAUTERY MODE ACTIVATED. THE PATIENT WAS THEN FITTED WITH A LIFEVEST. DUE TO THE PATIENT'S CURRENT MEDICAL CONDITION, A SYSTEM REVISION WAS PLANNED FOR APPROXIMATELY SIX MONTHS OUT. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611935 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R 4047| N119| H210| 4135| 4086| 4543