BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2050228 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03155
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM WAS EXPLANTED SECONDARY TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4548| 6947| 5076| 7274| H217