BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2781006 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13220
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 16, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. ANALYSIS REVEALED ALL CONDUCTOR COILS ARE FRACTURED APPROXIMATELY 43.9 CENTIMETERS FROM THE TERMINAL PIN. THE FRACTURE APPEARED TO BE AT PROXIMAL END OF THE SUTURE SLEEVE TIE-DOWN AREA. THE CLINICAL OBSERVATIONS WERE ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD DISPLAYED HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED. THE PATIENT WAS SEEN FOR A LEAD REVISION WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD IS TO BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    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 70 YR Hospitalization| L| R 4470| 0185| 1290| H219| 4471| 4518