BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3052505 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03847
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 FOLLOWING POCKET CLOSURE, POOR SENSING AND LOSS OF CAPTURE WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD. AS A RESULT, THE POCKET WAS RE-OPENED AND THE LEAD COULD NOT BE LOCATED IN A GOOD PLACE. THE PHYSICIAN DECIDED NOT TO PERFORM FURTHER REPOSITIONINGS AND THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156064 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R