BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2161556 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-06881
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS DUE TO LEAD DISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WAS ATTEMPTED TO BE REPOSITIONED WITHOUT SUCCESS. IN ADDITION, THE THRESHOLDS CONTINUED TO BE ELEVATED AND INSULATION DAMAGE WAS NOTED ON THE LEAD. THE DECISION WAS MADE TO REMOVE AND REPLACE THE LEAD. THE EXPLANTED LEAD WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 4480| 4543| N119| 0185