BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2053454 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03910
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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 THIS LEFT VENTRICULAR (LV) LEAD DISPLAYED IMPEDANCE MEASUREMENTS GREATER THAN 25,000 OHMS IN ALL VECTORS WITH NO CAPTURE. THE PATIENT IMPLANTED WITH THIS LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION. THE PHYSICIAN ORDERED AN XRAY, WHICH CONFIRMED A DISLODGEMENT. THE LEAD WAS PROGRAMMED OFF AND THE PHYSICIAN PLANNED TO REPOSITION THE LEAD IF PATIENT CONDITION WORSENED. THE PATIENT HAD REPORTED FATIGUE AS A RESULT OF THIS CLINICAL OBSERVATION.

    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 85 YR (B)(4)| 4543| H120| 4076