BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2052161 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03579
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 20, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED DURING A REVISION PROCEDURE. IT WAS ALSO NOTED THE THE LV LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. AT THIS TIME NO ADVERSE PATIENT EFFECTS WERE REPORTED AND A NEW LV LEAD WAS SUCCESSFULLY IMPLANTED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REVISION PROCEDURE, BOTH LEADS WERE CONFIRMED DISLODGED. THE RIGHT ATRIAL AND LEFT VENTRICLE (RV;LV) LEADS WERE SUCCESSFULLY REVISED DUE TO DISLODGEMENT. A NEW LV LEAD WAS SUCCESSFULLY IMPLANTED AND THE RA LEAD REMAIN IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS REPORTED. THE INVESTIGATION IS COMPLETE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R N119| 0181| 4136| 4549| 4592