BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2050253 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-05769
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    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 LV LEAD REMAIN ACTIVELY IN SERVICE, BUT THIS RV LEAD WAS SURGICALLY ABANDONED AS A RESULT OF LEAD FRACTURE. IF 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 THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND THE 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. IT WAS NOT KNOWN AT THE TIME OF THIS INITIAL REPORT WHETHER ACTUAL ASYSTOLE GREATER THAN 2 BEATS/SECONDS HAD OCCURRED. A CONDUCTOR FRACTURE OF THE RV LEAD WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0138

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 4542| 0138| 4480| H227| 4136