BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 875867 · Received July 5, 2007

    Report

    Report Number
    2124215-2007-99657
    Event Type
    Death
    Date Received
    July 5, 2007
    Date of Event
    December 11, 2004
    Report Date
    June 29, 2007
    Manufacturer
    CLONMEL
    Product Code
    NIK
    Report Source
    Manufacturer report
    Reporter Location
    US

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IT IS SUSPECTED THAT THE DEVICE WAS BURIED WITH THE PATIENT. IF THE DEVICE IS RETURNED THE EVENT WILL BE UPDATED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED. ON JUNE 23, 2005, GUIDANT CORPORATION (NOW BOSTON SCIENTIFIC CRM) ISSUED A PHYSICIAN COMMUNICATION REGARDING A MAGNETIC SWITCH INSIDE AFFECTED DEVICES MAY STICK IN THE CLOSED POSITION, POTENTIALLY INHIBITING TACHYARRHYTHMIA THERAPY (WITH NO IMPACT ON BRADYCARDIA PACING) AND AFFECTING BATTERY LONGEVITY. CHANGES TO TRY TO PREVENT THIS ANOMALY WERE MADE JULY 2005. THIS DEVICE WAS MANUFACTURED BEFORE JULY 2005, AND IS INCLUDED IN THIS POPULATION. ON MAY 12 2006, GUIDANT CORPORATION (NOW BOSTON SCIENTIFIC CRM) ISSUED A PHYSICIAN COMMUNICATION LETTER SPECIFICALLY REGARDING DEVICES IMPLANTED SUBPECTORALLY WITH SERIAL NUMBERS FACING THE PATIENT'S RIBS AND POSSIBLE DEVICE MALFUNCTIONS ASSOCIATED WITH THIS UNCOMMON ORIENTATION. THIS DEVICE IS INCLUDED IN THIS ADVISORY POPULATION, HOWEVER, WE DO NOT HAVE SUFFICIENT INFORMATION TO DETERMINE IF IT WAS IMPLANTED IN THAT ORIENTATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPIRED DUE TO 'COMPLICATIONS RELATED TO THE FAILURE OF THE DEVICE.' NEW INFORMATION RECEIVED INDICATES THAT THIS PATIENT AND/OR REPRESENTATIVE OF THE PATIENT HAS RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR NIK CLONMEL H179

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death