BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2042301 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01445
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT DURING THIS NORMAL GENERATOR REPLACEMENT PROCEDURE, THIS LEFT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AS IT WAS NO LONGER CAPTURING AND WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD REMAINS IN SERVICE. EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER THE SALES REPRESENTATIVE IN THIS PATIENT'S TERRITORY WAS NOT AWARE OF THIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT REPORTED THEIR LEFT VENTRICULAR LEAD IS BROKEN. THERE HAVE BEEN NO REPORTS OF THIS FROM MEDICAL PERSONNELL TO THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 0185| 4542| 4543| H170| 4087