BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2163400 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07337
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    September 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY THE COMPLETE LEAD WAS RECEIVED. THERE WAS DRIED BLOOD/BODY FLUID IN THE LEAD LUMEN. THE CONDUCTOR COILS WERE DEFORMED 102-107 MILLIMETERS FROM THE TERMINAL PIN, WHICH WAS LIKELY DUE TO A GRABBING TOOL. THERE WERE ALSO CUTS NOTED IN THE INSULATION. THE CLINICAL OBSERVATION WAS UNABLE TO BE REPRODUCED DURING ANALYSIS. THE LEAD WAS FOUND TO BE ELECTRONICALLY CONTINUOUS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED DISLODGEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THIS LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    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 66 YR Required Intervention N119| 4543| (B)(4)| 0181| 0171