BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2173299 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10325
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 THIS LEFT VENTRICULAR (LV) LEAD DISLODGED FROM ITS ORIGINAL IMPLANTED SITE CAUSING DIAPHRAGMATIC STIMULATION AND HIGH DEFIBRILLATION THRESHOLDS. THIS LEAD WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PHYSICIAN WAS UNABLE TO PLACE ANOTHER LV LEAD DUE TO THE SMALL PATIENT'S ANATOMY. THE DEVICE HAS BEEN PROGRAMMED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS REPORTED FROM THIS PROCEDURE.

    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 62 YR Required Intervention N119| 0184| 4542| 4469| 4555