BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2042343 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02123
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    August 30, 2006
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN (B)(6) GUIDANT, NOW BOSTON SCIENTIFIC ISSUED A PHYSICIAN COMMUNICATION DESCRIBING VARIOUS CLINICAL BEHAVIORS ASSOCIATED WITH A MAGNETIC SWITCH. MANUFACTURING CHANGES TO PREVENT THIS FAILURE WERE MADE IN (B)(6) 2005. THIS DEVICE WAS MANUFACTURED BEFORE (B)(6) 2005 AND IS INCLUDED IN THIS ADVISORY POPULATION. WHILE THIS DEVICE WAS APART OF THE ADVISORY POPULATION, WE DO NOT HAVE SUFFICIENT INFORMATION TO DETERMINE IF THIS DEVICE BEHAVED IN THE MANNER DESCRIBED IN THE ADVISORY. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION IN AUGUST 2006 THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WHICH IS INCLUDED IN THIS ADVISORY POPULATION RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS AGAINST DEVICE MALFUNCTION. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED IN (B)(6) 2009 DUE TO NORMAL BATTERY DEPLETION. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CONTACTED PATIENT SUPPORT IN (B)(6) 2011 TO REPORT THAT THIS DEVICE HAD BEEN CHECKED AND WAS INFORMED THAT THE DEVICE "WAS FINE" AND WITHIN ONE WEEK "WAS TOTALLY DEAD". PATIENT SUPPORT EXPLAINED THAT DETAILED INFORMATION INCLUDING PROGRAMMED SETTINGS, VOLTAGE STATUS, THERAPY USAGE, DEVICE ANALYSIS, ETC WAS REQUIRED IN ORDER TO ADDRESS THE QUESTION. PATIENT SUPPORT RECOMMENDED THAT THE PATIENT DISCUSS THIS FURTHER WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 4243| 0148| 4512| H175| 1861