BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3910493 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-10016
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THIS LV LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388709 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R D154VRC| 6947| 4542| N141| 4087| MISMATCH