BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 3921854 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12925
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400547 EASYTRAK IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4513

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R H179| 1550| 4592| 4312| 4518| H219| 1625| 4470| 0158| 0041| N164| 4513