BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 2803140 · Received March 3, 2006

    Report

    Report Number
    2124215-2006-99343
    Event Type
    Death
    Date Received
    March 3, 2006
    Date of Event
    February 16, 2006
    Report Date
    March 3, 2006
    Manufacturer
    CLONMEL
    Product Code
    NIK
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. EVENT CONCLUSION: AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO GUIDANT FOR ANALYSIS. THERE IS NO ADDITIONAL INFO RELATED TO THIS EVENT. GUIDANT WILL CONTINUE TO INVESTIGATE THE COMPLAINT, AND IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVENT WILL BE REOPENED. ON (B)(6) 2005, GUIDANT ISSUED AN ADVISORY UPDATE DESCRIBING VARIOUS CLINICAL BEHAVIORS ASSOCIATED WITH A MAGNETIC SWITCH. MFG CHANGES TO PREVENT THIS FAILURE WERE MADE IN 07/2005. THIS DEVICE WAS MANUFACTURED BEFORE 07/2005 AND IS INCLUDED IN THIS POPULATION. GUIDANT DOES NOT HAVE SUFFICIENT INFO TO DETERMINE THAT THIS DEVICE BEHAVE IN THE MANNER DESCRIBED IN THE ADVISORY.

    Description of Event or Problem · 1

    GUIDANT RECEIVED INFO THAT THIS DEVICE WAS PART OF A LEGAL ACTION AND THE PT PASSED AWAY TWO YEARS AGO. GUIDANT HAS NO SPECIFIC INFO AS TO THE DEVICE INVOLVEMENT IN THE PT'S DEATH.

    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 75 YR Death