BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 1862118 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15769
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 CRM RECEIVED INFORMATION THAT THIS PACING SYSTEM WAS BEING EXPLANTED DUE TO INFECTION. IT WAS ALSO REPORTED THAT THE ASSOCIATED LEADS HAD ERODED THROUGH THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR H175| H125| 4512| 4285| 1230| 0154| 1280| 4269