BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 900830 · Received August 21, 2007

    Report

    Report Number
    2124215-2007-99699
    Event Type
    Death
    Date Received
    August 21, 2007
    Date of Event
    April 5, 2006
    Report Date
    August 16, 2007
    Manufacturer
    CLONMEL
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AFTER IT WAS DETERMINED THAT IT WAS A LAWYER POSING AS A PT AND SEEKING TO HAVE THE DEVICE INTERROGATED, WE INITIATED A PROCESS FOR MAKING MORE APPROPRIATE ARRANGEMENTS FOR GATHERING INFO ABOUT THIS DEVICE. 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 THE ORIENTATION DESCRIBED IN THE ADVISORY AND IF THIS DEVICE WAS SUBJECTED TO THE MANNER DESCRIBED IN THE ADVISORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPIRED DUE TO UNSPECIFIED CAUSE. AT THE TIME OF THE PT'S DEATH THERE WERE NO PRODUCT PERFORMANCE ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR NIK CLONMEL H170

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death