BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 2243417 · Received September 12, 2011

    Report

    Report Number
    2124215-2011-15489
    Event Type
    Death
    Date Received
    September 12, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. 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 PATIENT WITH THIS IMPLANTED DEVICE PASSED AWAY AFTER COLLAPSING AT HOME OVERNIGHT ON THE SAME DAY THAT THIS DEVICE WAS IMPLANTED. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE PATIENT HAD BEEN UPGRADED FROM AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH NO ISSUES DURING THE PROCEDURE. THE POST-OPERATIVE DEVICE CHECK SHOWED NO ANOMALIES, AND LEAD MEASUREMENTS WERE NORMAL. THE PATIENT WAS DISCHARGED, AND LATER THAT NIGHT, COLLAPSED AND MAY HAVE STRUCK HIS HEAD. THE PATIENT COULD NOT BE REVIVED AND WAS PRONOUNCED DEAD. IT WAS NOT KNOWN IF THERE WERE ANY ALLEGATIONS AGAINST THE DEVICE. AN AUTOPSY WAS REQUESTED BY THE CORONER, BUT THE PATIENT'S SPOUSE DID NOT WANT ONE PERFORMED. THE REPRESENTATIVE HAD REQUESTED THE PHYSICIAN'S PERMISSION TO INTERROGATE THE DEVICE.

    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 75 YR Death 0154| 4543| 1861| N119| T165| 4470