BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3041275 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03408
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE PACING IMPEDANCES GREATER THAN 2000 OHMS AND A LOSS OF CAPTURE (LOC) WERE OBSERVED ON THIS LEFT VENTRICULAR (LV) LEAD. THE LOCAL FIELD REPRESENTATIVE DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TESTING VARIOUS PROGRAMMING CONFIGURATIONS FOR ROOT CAUSE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT CAPTURE AND OUT OF RANGE IMPEDANCE MEASUREMENTS WERE RESTORED BY CHANGING THE LV PACING VECTOR. AN ISSUE WAS FOUND WITH THE LEAD ELECTRODE TIP THAT WAS THE CONCLUDED CAUSE TO THE ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143907 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R 4086| 0184| 4543| 4271| 4088| 4087| 1270| H217| 4035| 1290| 4137| H227