BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 1861027 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15207
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    February 12, 2009
    Report Date
    July 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER WAS ADMITTED TO THE HOSPITAL DUE TO DECOMPENSATION FROM LACK OF BIVENTRICULAR PACING. UPON INTERROGATION OF THE DEVICE, LEFT VENTRICULAR LOSS OF CAPTURE WAS NOTED. (RIGHT VENTRICULAR PACING WAS BEING PROVIDED) THE LEFT VENTRICULAR LEAD WAS TESTED WITH THE PROGRAMMER AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. A DEVICE MALFUNCTION WAS SUSPECTED. DUE TO THE CONDITION OF THE PATIENT; THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H140

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening