BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2170002 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10096
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD WAS RETURNED. DRIED BLOOD AND BODY FLUID WAS NOTED IN THE LEAD LUMEN. THE CONDUCTOR COILS WERE DEFORMED AT 135, 340 AND 652 MILLIMETERS (MM) FROM THE TERMINAL PIN. CUTS IN THE POLYURETHANE INSULATION WERE NOTED AT 172 AND 175 MM FROM THE TERMINAL PIN. MELTED INSULATION, DUE TO ELECTROCAUTERY, WAS SEEN AT 103, 105, 110, 117 AND 120 MM FROM THE TERMINAL PIN. THE REPORTED INSULATION DAMAGE WAS CONFIRMED THROUGH TESTING. THE CLINICAL OBSERVATION OF DISLODGEMENT WAS NOT ABLE TO BE CONFIRMED THROUGH TESTINGS.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. 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 THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS SCHEDULED TO UNDERGO AN LV LEAD ADDITION. IT WAS THOUGHT THAT THE PATIENT DID NOT HAVE AN LV LEAD. WHEN THE PHYSICIAN OPENED THE POCKET, IT WAS DISCOVERED THAT AN LV LEAD EXISTED BUT IT WAS NOT CAPTURING IN ANY VECTOR. FLUOROSCOPY SHOWED THAT A MAJORITY OF THE LEAD WAS IN THE POCKET. UPON REMOVAL OF THE LEAD, INSULATION DAMAGE WAS NOTED. DUE TO PATIENT ANATOMY, A NEW LV LEAD WAS NOT PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE 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 71 YR Required Intervention 0184| N119| 4518| H215| 4135