BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1853465 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14802
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS IN THE TIP-TO-RING CONFIGURATION. ELECTRONIC REPOSITIONING SHOWS STABLE IMPEDANCE MEASUREMENTS ONLY IN THE RING-TO-COIL CONFIGURATION. TECHNICAL SERVICES (TS) DISCUSSED THE IMPORTANCE OF ELECTRONIC REPOSITIONING AND THEY COULD MONITOR THE LEAD; HOWEVER, IT WAS THE PHYSICIAN'S DIGRESSION IF THEY WANTED TO REVISE THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE HIGH PACING IMPEDANCE MEASUREMENTS HAS NOT BEEN DETERMINED. THE PHYSICIAN'S PLAN IS TO MONITOR THE PATIENT ONGOING AND ATTEMPTING TO HAVE THE PATIENT BEGIN USING HIS LATITUDE MONITOR AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 0184| H219| 4054| 4518