BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3761275 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-03668
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD'S CONDUCTOR WAS DAMAGED. THUS, THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS IMPLANTED. THE LV LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240274 EASYTRAK 3 IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R N119| 0185| 4470| 4549