BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL

    MDR report key: 913096 · Received September 14, 2007

    Report

    Report Number
    2124215-2007-99716
    Event Type
    Death
    Date Received
    September 14, 2007
    Date of Event
    March 18, 2005
    Report Date
    September 13, 2007
    Manufacturer
    CLONMEL
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AS OF TODAY THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IT MAY HAVE BEEN BURIED WITH THE PATIENT. IF THE DEVICE IS RETURNED THE EVENT WILL BE UPDATED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE THE EVENT WILL BE UPDATED. ON JUNE 17, 2005 GUIDANT CORP (NOW BOSTON SCIENTIFIC CRM) ISSUED A PHYSICIAN COMMUNICATION REGARDING DETERIORATION IN A WIRE INSULATOR SURROUNDING A WIRE WITHIN THE LEAD CONNECTOR BLOCK WHICH, IN CONJUNCTION WITH OTHER FACTORS, COULD CAUSE A SHORT CIRCUIT AND LOSS OF DEVICE FUNCTION. CHANGES TO TRY TO PREVENT THIS ANOMALY WERE MADE IN AUG 2004. THIS DEVICE WAS MFG ON OR BEFORE AUG 26, 2004, AND IS INCLUDED IN THIS POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPIRED DUE TO UNSPECIFIED CAUSE. AT THE TIME OF THE PATIENT'S DEATH THERE WERE NO PRODUCT PERFORMANCE ALLEGATIONS. NEW INFORMATION INDICATES THAT THIS PATIENT OR A REP FOR THE PATIENT HAS RETAINED AN ATTORNEY AND RECENTLY SUBMITTED PAPERWORK AS PART OF THE LITIGATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK CLONMEL H135

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death