BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1944941 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19648
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THERE WAS A POTENTIAL LV LEAD CONDUCTOR FRACTURE SUSPECTED. HOWEVER, THERE WAS NOTHING NOTABLE ON THE CHEST X-RAY. AN LV LEAD REVISION/REPLACEMENT PROCEDURE PLANNED TO BE PERFORMED AT A DATE IN THE NEAR FUTURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THERE WAS ALSO AN INCREASE IN PACING THRESHOLD MEASUREMENTS. R- WAVE SENSING HAD DECREASED TO 2 MV FROM 6 MV. THE PATIENT WAS SENT TO HAVE A CHEST X-RAY PERFORMED.

    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 72 YR H210| 4542| 0185| 4087