BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2050552 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-05768
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THE CRT-D AND THIS LV LEAD REMAIN ACTIVELY IN SERVICE. THE RV LEAD WAS SURGICALLY ABANDONED AS A RESULT OF THE EVIDENT FRACTURE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN ASSOCIATION WITH THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND THIS LEFT VENTRICULAR (LV) LEAD DID EXHIBIT PACING IMPEDANCE GREATER THAN 2000 OHMS ON BOTH THE RV AND LV LEADS. THIS WAS EVIDENT TO HAVE INCREASED OVER TIME. THE LV LEAD HAD BEEN PROGRAMMED TIP TO COIL AND WHEN THE COIL WAS REMOVED FROM THE SYSTEM CONFIGURATION, IMPEDANCE WAS NORMAL. RV THRESHOLD HAD RISEN TO 5 VOLTS AT 1 MILLISECOND. SHOCK LEAD IMPEDANCE WAS EVIDENT TO HAVE INCREASED ABOUT 50% FROM THE 60S TO THE RANGE OF 90 OHMS PACE IMPEDANCE. A STORED EVENT WAS IDENTIFIED WHICH INDICATED RV NOISE, CAUSING OVERSENSING. THIS NOISE WAS UNABLE TO BE REPRODUCED WITH ISOMETRICS. NO INAPPROPRIATE THERAPY HAD BEEN DELIVERED, BUT THE PATIENT DID REPORT MORE FATIGUE AND SHORTNESS OF BREATH. A CONDUCTOR FRACTURE OF THE RV LEAD WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)