BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 3813662 · Received May 15, 2014

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    Report

    Report Number
    2124215-2014-10890
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. UPON LEAVING THE OPERATING ROOM, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND EXPIRED. THIS OCCURRED APPROXIMATELY 30 MINUTES AFTER THE EXPLANT PROCEDURE. THE CAUSE OF DEATH WAS NON-ISCHEMIC CARDIOMYOPATHY. THE FIELD REPRESENTATIVE NOTED THE VENTRICULAR FIBRILLATION AND SUBSEQUENT DEATH WERE NOT PRODUCT-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290543 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| L| R 4087| 4513| H179| N118| 0158| H135