BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1864041 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15735
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED UPDATED INFORMATION THAT WHEN SYSTEM BECAME INFECTED - THE CAUSE IS UNKNOWN - THE PHYSICIAN OPTED TO TREAT IT WITH ANTIBIOTICS AND THE DEVICE SYSTEM REMAINS IMPLANTED. THE PATIENT INITIALLY WAS HOSPITALIZED FOR TREATMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS RELATED TO THIS PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4525

    Patients

    Seq Age Sex Outcome Treatment
    1