BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3041165 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01658
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS BEING RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN THE LEAD IS RETURNED AND EVALUATED.

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED DAMAGE TO THE CONDUCTOR COILS AND RESISTANCE TESTING CONFIRMED THE LEAD WAS NOT ELECTRICALLY CONTINUOUS. ANALYSIS REVEALED THE COILS WERE FRACTURED APPROXIMATELY 29.2 CM FROM THE TERMINAL PIN, DISTAL END OF THE SUTURE SLEEVE TIE-DOWN AREA. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS DUE TO A FRACTURE. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144178 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization 3830| P1501DR| 4542| 0181| N119