BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 1874085 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18264
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 6, 2008
    Report Date
    September 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS LV LEAD REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WAS MOST LIKELY DISLODGED. THE IMPLANTING PHYSICIAN AT THE NORMAL DEVICE CHANGEOUT INDICATED SUSPECTED DISLODGEMENT AS THRESHOLDS WERE NOT OPTIMAL AND SENSING WAS NOT ALWAYS APPROPRIATE. DESPITE SENSING RE-CONFIGURATION, THIS LV LEAD HAD OVERSENSED AND INHIBITED LV PACING. THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THE PATIENT WAS ASYMPTOMATIC. THE LOCAL AREA SALES REPRESENTATIVE PLANNED TO TRY VARIOUS SENSING CONFIGURATIONS TO MITIGATE THE ISSUE. AT THE TIME OF THIS REPORT, NO ACTION WAS KNOWN TO HAVE BEEN TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 1555| A135| 4087| 1746| 0158| 0074| 4549| H210