BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2173270 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10900
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH DRIED BLOOD AND BODY FLUID IN THE LEAD LUMEN. VISUAL INSPECTION FOUND THAT THE CONDUCTOR COILS WERE DEFORMED AT 472 MM FROM THE TERMINAL PIN AND THERE WERE CUTS IN THE POLYURETHANE INSULATION AT 472 AND 485 MM FROM THE TERMINAL PIN. PER ANALYSIS, THE DEFORMED COILS AND CUTS IN INSULATION APPEAR TO BE FROM REMOVAL OF THE SUTURE SLEEVE. A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CATURE AND HAD DISLODGED. THE PHYSICIAN ELECTIVELY EXPLANTED THE LEAD. A NEW LV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4549| 0170| 4592| 0184| 4555| N119| 4135| MISMATCH