BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1952817 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24421
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS PUT THROUGH AND PASSED A SERIES OF DIAGNOSTIC TESTS THAT VERIFIED THE ELECTRICAL CONTINUITY AND INSULATION INTEGRITY OF THE LEAD. IT WAS CONCLUDED THAT THE LEAD HAD DISLODGED AND LOSS OF CAPTURE COULD NOT BE CONFIRMED THROUGH LABORATORY TESTING. EVIDENCE AND PAST EXPERIENCE SUGGESTS THAT LEAD DISLODGEMENT CAN BE THE RESULT OF UNIQUE PATIENT PHYSIOLOGY AND/OR IMPLANT TECHNIQUE.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY AND IS CURRENTLY UNDERGOING LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS IMPLANTED TRANSVENOUS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED AND WAS EXHIBITING LOSS OF LV CAPTURE. THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY LABORATORY. THE CHRONIC LV LEAD WAS EXTRACTED AND A REPLACEMENT LV LEAD WAS IMPLANTED WITHOUT INCIDENT. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS REPLACEMENT LV LEAD HAD DISLODGED AND WAS EXHIBITING LV LOSS OF CAPTURE. THE PATIENT HAS BEEN SCHEDULED FOR EXTRACTION OF THE REPLACEMENT LV LEAD AND IMPLANT OF AN LV EPICARDIAL LEAD. THE CHRONIC LV LEAD WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

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    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 67 YR Hospitalization| L| R 0185| 4549| T175| 4592| N119