BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3771552 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09137
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248705 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 4513| H175| 0158| 4457| H229| 4543| H135| 4470| 1280| N119