BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1712402 · Received June 7, 2010

    Report

    Report Number
    2124215-2010-12137
    Event Type
    Death
    Date Received
    June 7, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER COMMUNICATION FROM THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE REVEALED THAT THERE WERE NO PHYSICIAN-RELATED ALLEGATIONS MADE AGAINST THIS DEVICE. IT WAS ALSO NOTED THAT SINCE THIS PATIENT WAS PACER-DEPENDENT AND HAD BEEN CLEARED FOR A NEW IMPLANT AFTER RECEIVING ANTIBIOTICS, THE PHYSICIAN HAD ELECTED TO IMPLANT A NEW SYSTEM. IT IS UNKNOWN AT THIS TIME WHETHER THE DEVICE WAS EXPLANTED OR BURIED WITH THE PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D, (B) (4)), DEFIBRILLATION, TRANSVENOUS, AND CORONARY SINUS LEADS WERE EXPLANTED DUE TO AN INFECTION. A PHYSICIAN FURTHER DETERMINED THAT THE POCKET BECAME INFECTED DUE TO A SKIN BIOPSY PERFORMED NEAR THE DEVICE SITE. IT WAS LATER REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENT RECEIVED ANTIBIOTICS FOR THE INFECTION AND, AFTER THE EXPLANT OF THIS CRT-D, AN EXTERNAL PACER WAS USED. TWO DAYS LATER, A NEW BOSTON SCIENTIFIC CRT-D WAS IMPLANTED. THE PATIENT'S FAMILY FURTHER REPORTED THAT THE PATIENT SUBSEQUENTLY DIED DUE TO COMPLICATIONS RELATED TO THE INFECTION AND NOTED THAT THEY THOUGHT THE SECOND DEVICE HAD BEEN IMPLANTED TOO SOON AFTER REMOVAL OF THE FIRST 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 88 YR Death 4087| 1280| N119| 4053| 4549| 0185