BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2190546 · Received August 4, 2011

    Report

    Report Number
    2124215-2011-13299
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WAS REMOVED FROM SERVICE FOR UNSPECIFIED REASON. THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE HAD BEEN INQUIRING ABOUT LASER EXTRACTION GUIDELINES FOR THIS MODEL OF LEAD. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX GUIDANT PUERTO RICO BV 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention