BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 1873854 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17692
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS IMPLANTED WITHOUT A RIGHT VENTRICULAR (RV) LEAD. THE PATIENT EXPERIENCED ASYSTOLE WHEN THE DEVICE WAS PROGRAMMED VVI DURING SENSITIVITY TESTING. TECHNICAL SERVICES (TS) DISCUSSED THE PLUGGED RV PORT WAS CONSIDERED OFF-LABEL USE. AS THE PORT WAS STILL SUSCEPTIBLE TO NOISE, TS RECOMMENDED ADJUSTING THE SENSITIVITY SETTINGS TO REDUCE LIKELIHOOD OF CONTINUED OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H120

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening