BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2172850 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10189
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DISTAL PORTION OF THIS LEFT VENTRICULAR (LV) LEAD IS SUSPECTED TO BE FRACTURED. ANY TIME IT IS PROGRAMMED USING THE LV-TIP CONFIGURATION HIGH IMPEDANCE AND THRESHOLD VALUES ARE EXHIBITED. THE HEALTH CARE PROVIDER WAS ABLE TO WORK AROUND THE ISSUE BY PROGRAMMING THE LV PACING CONFIGURATION DIFFERENTLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THIS LEAD REMAINS IN SERVICE.

    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 51 YR H177| 0185| N119| 4543| 4087