BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3211618 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09256
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THE PRESENCE OF DRIED BLOOD/BODY FLUID IN THE LUMEN, AND A CUT IN THE LEAD INSULATION 415 MILLIMETERS (MM) FROM THE TERMINAL PIN. ANALYSIS NOTED THAT THE TIP WAS INTACT AND UNDAMAGED. ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) IN ALL PROGRAMMED VECTORS. ADDITIONALLY, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. X-RAY IMAGING REVEALED THAT THE LEAD HAD DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED THREE WEEKS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310165 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R N141| 0158| E110| 4549| 4473