BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2053280 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04952
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. LEAD DAMAGED WAS OBSERVED, INCLUDING, FLATTENED INSULATION AND FRACTURED CONDUCTOR COILS, 530MM TO 545MM FROM THE TERMINAL PIN. THIS DAMAGE WAS LIKELY A RESULT BY ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. UPON DEVICE EVALUATION, THE OUT OF RANGE MEASUREMENTS WERE REPRODUCED WITH LIGHT PRESSING ON THE PATIENTS' CHEST. AN XRAY REVEALED A LEAD FRACTURE. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS EXTRACTED AND REPLACED SUCCESSFULLY. NO FURTHER COMPLICATIONS WERE OBSERVED.

    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 60 YR Hospitalization| R 4543| 0157| N119| MISMATCH| T127