BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1944809 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-21364
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE LEAD IDENTIFIED DRIED BODILY FLUID IN THE LEAD LUMEN AND ON THE TERMINAL PIN. THE CONDUCTOR COILS WERE DEFORMED IN MANY AREAS OF THE LEAD. THE LEAD WAS PUT THROUGH AND FAILED ELECTRICAL CONTINUITY TESTING. THE POLYURETHANE TUBING WAS PUCKERED APPROXIMATELY 243-253 MM FROM THE TERMINAL PIN. THIS APPEARED TO BE THE SUTURE SLEEVE TIE DOWN SITE. THE INNER INSULATION IS WORN/TORN APPROXIMATELY 267-268MM FROM THE TERMINAL PIN. ADDITIONALLY, THE CONDUCTOR COILS WERE FRACTURED APPROXIMATELY 267-268MM FROM THE TERMINAL PIN AND THE LEAD'S POLYURETHANE APPEARED BENT IN THIS AREA. IT WAS CONCLUDED THAT THE CLINICAL ALLEGATION OF LEAD FRACTURE WAS CONFIRMED BY XRAY AND CONTINUITY TESTING. THIS FRACTURE APPEARS TO BE JUST DISTAL OF THE SUTURE SLEEVE TIE DOWN AREA.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE WAS TAKEN OUT-OF-SERVICE (OOS). THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A LEAD REVISION PROCEDURE. THE LEFT VENTRICULAR (LV) LEAD WAS EXTRACTED DUE TO CONDUCTOR FRACTURE. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE BECAUSE THE LV RING SET SCREW WAS NOT OPERATING PROPERLY. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE LV PORT OF THE REPLACEMENT DEVICE HAD BEEN PLUGGED DUE TO THE UNSUCCESSFUL MULTIPLE ATTEMPTS TO IMPLANT TRANSVENOUS LV LEADS DUE TO PATIENT CONDITION. THE PATIENT WAS THEN PRESENTED TO THE OPERATING ROOM AND AN EPICARDIAL LV LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 4542| H220| N119| T175| 4136| 0185| 4548