BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1983925 · Received February 10, 2011

    Report

    Report Number
    2124215-2011-02504
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    November 4, 2010
    Report Date
    February 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE FIELD WERE UNABLE TO DETERMINE IF THE FIBRILLATION WAS ATRIAL FIBRILLATION OR VENTRICULAR FIBRILLATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ADVOCATE THAT THE PATIENT DIED DUE TO VENTRICULAR FIBRILLATION. HE WAS CONCERNED THAT THE DEVICE DID NOT TREAT THE VENTRICULAR FIBRILLATION. 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 FROM A PATIENT ADVOCATE THAT THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL POST IMPLANT WITH CHEST PAIN. THE PHYSICIAN MONITORED THE PATIENT FOUR DAYS AND HAD THE FIELD REPRESENTATIVE CHECK THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS WELL. THE PATIENT ADVOCATE NOTED THE PHYSICIAN AND FIELD REPRESENTATIVE INFORMED THE PATIENT THAT THE CRT-D WAS ADJUSTED BUT HIS HEARTBEAT SEEMED UNCONTROLLABLE. EVEN THOUGH THIS WAS THE CASE THE PATIENT WAS RELEASED TO HOME AND LATER DIED. THE PATIENT ADVOCATE REPORTED THE PATIENT DIED FROM FIBRILLATION. HE QUESTIONED WHY THE DEVICE DID NOT PREVENT THE FIBRILLATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death N119| 4470| T125| 4543| 0158| H170