BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2050591 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04645
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THIS LEAD WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS INADVERTENTLY DISCARDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD BECAME DISLODGED FOLLOWING THE PLACEMENT OF A SUPERIOR VENA CAVA (SVC) PORT. A LEAD REVISION PROCEDURE WAS PERFORMED AND THIS LV LEAD WAS SUCCESSFULLY EXPLANTED. A NEW LV LEAD WAS IMPLANTED AND NO ADDITIONAL ADVERSE PATIENT EVENTS WERE NOTED. A REQUEST FOR THE RETURN OF THE LEAD HAS BEEN MADE.

    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 68 YR Hospitalization| L| R 4525| 4518| 0175| H215| 4136