BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2042285 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01802
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 18, 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

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, TOTALING 396 MILLIMETERS (MM). DRIED BLOOD/BODY FLUID WAS NOTED IN THE LEAD LUMEN. THE CONDUCTOR COILS WERE STRETCHED AND DEFORMED 280 - 294 MM FROM THE TERMINAL PIN. THIS MOST LIKELY OCCURRED DURING THE REMOVAL OF THE SUTURE SLEEVE. ELECTRO-CAUTERY WAS NOTED TO HAVE MELTED THE INSULATION AT 287 MM FROM THE TERMINAL PIN. THE PORTION OF THE LEAD THAT WAS RETURNED WAS FOUND TO BE ELECTRICALLY CONTINUOUS, HOWEVER, WE CAN NOT RULE OUT A LEAD FRACTURE AS WE WERE UNABLE TO PERFORM TESTING ON THE ENTIRE LEAD.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISPLAYED HIGH, OUT OF RANGE PACING IMPEDANCES. A LEAD REVISION PROCEDURE WAS PERFORMED WHERE IT WAS DISCOVERED VIA FLUOROSCOPY THAT THE LEAD HAD FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC LEAD. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE LEAD IS TO BE RETURNED FOR ANALYSIS.

    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 77 YR 0184| 0180| N119| 0175| 4469| 4543| 4470| 4592| H210