BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2170389 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10258
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LV LEAD WAS DISCARDED AT THE HOSPITAL, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION, THAT DURING A ROUTINE FOLLOW-UP, IT WAS OBSERVED THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOSS OF CAPTURE (LOC), P WAVE OVERSENSING AND NO R WAVE SENSING. AN X-RAY WAS PERFORMED, AND REVEALED LV DISLODGEMENT. THE DECISION WAS MADE TO IMPLANT A NEW LV LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    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