BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1813529 · Received August 24, 2010

    Report

    Report Number
    2124215-2010-16532
    Event Type
    Death
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE SPOKE DIRECTLY WITH THE PATIENT'S FOLLOWING PHYSICIAN, WHO NOTED THAT THE SIGNED DEATH CERTIFICATE STATES THE CAUSE OF DEATH AS CARDIOPULMONARY ARREST, ACUTE RENAL FAILURE AND HEART FAILURE. THE FOLLOWING PHYSICIAN WAS UNAWARE OF A STAPH INFECTION OF ANY KIND, AND MADE NO ALLEGATIONS AGAINST THE PERFORMANCE OF THE DEVICE. AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE WAS BURIED WITH THE PATIENT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT PASSED AWAY. A PATIENT ADVOCATE CLAIMED THAT THE PATIENT MAY HAVE CONTRACTED A STAPH INFECTION WHEN HER CURRENT DEVICE WAS IMPLANTED APPROXIMATELY TWO MONTHS EARLIER, AND THAT THIS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| O 0154| H219| 4469| 1861| N118| 4518