BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1860497 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15061
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF FURTHER INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS ONE DAY POST-IMPLANT AND A DISLODGEMENT WAS SUSPECTED. THE NEXT DAY, THE LEAD WAS REVISED (IT WAS DISCARDED) AND REPLACED. NO ALLEGATIONS WERE MADE AGAINST THE LEAD AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1