BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1895506 · Received November 10, 2010

    Report

    Report Number
    2124215-2010-21933
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    June 9, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS OVERSENSING ATRIAL ACTIVITY WHICH INHIBITED BI-VENTRICULAR PACING. TECHNICAL SERVICES (TS) DISCUSSED ADJUSTING THE SENSING VECTOR TO TRY TO MITIGATE THIS SENSING ISSUE. AN ALERT WAS ALSO ISSUED FOR LOW LV PACING PERCENTAGE. A REVIEW OF DAILY MEASUREMENTS REVEALED THAT THERE WAS A LARGE DECLINE IN LV IMPEDANCE, CORRELATING WITH WHEN THE SENSING ISSUE BEGAN. IT WAS LATER REPORTED THAT THE LV LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN 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 46 YR Required Intervention N119| H179| H177| 0186| 0148| MISMATCH| 4543| 4470| 4518