BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK CD

    MDR report key: 1412356 · Received July 8, 2009

    Report

    Report Number
    2124215-2009-14625
    Event Type
    Death
    Date Received
    July 8, 2009
    Date of Event
    September 28, 2002
    Report Date
    July 8, 2009
    Manufacturer
    PCI PLANT - ST PAUL
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC CRM FOR ANALYSIS. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PT IMPLANTED WITH THIS DEVICE WAS INVOLVED IN A CLINICAL RESEARCH STUDY ASSESSING POTENTIAL PREDICTORS OF EARLY MORTALITY IN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECIPIENTS. DATA FROM THIS STUDY REVEALED AN OVERALL ONE-YEAR MORTALITY RATE OF 16%. THE PTS PARTICIPATING IN THIS STUDY APPEARED TO BE ON AVERAGE OLDER, ON MEDICATIONS AND A LARGE PERCENTAGE DEMONSTRATED A HISTORY OF ATRIAL FIBRILLATION, VENTRICULAR TACHYCARDIA AND/OR SYNCOPE. IT WAS REPORTED THAT THE INCREASED MORTALITY WAS THUS LIKELY MULTIFACTORIAL AND THAT INCREASES IN HEART FAILURE, STROKE AND DRUG TOXICITY MAY HAVE PLAYED A ROLE; HOWEVER, THE CAUSE OF DEATH WAS KNOWN IN ONLY 67% OF PTS. THE PT WITH THIS PARTICULAR ICD EXPIRED FOR UNKNOWN REASON(S) AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK CD IMPLANTABLE CHF GENERATOR NIK PCI PLANT - ST PAUL 1823

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death 4513| 4017| 1823| 0148