BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1870046 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16890
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED A POSSIBLE INTERMITTENT SETSCREW OR CONNECTION ISSUE, LEAD DISLODGEMENT, OR THAT THE POSITION OF THE LEAD WAS NOT IN CONTACT WITH VIABLE TISSUE. THE PHYSICIAN COULD MONITOR OR PERFORM AN INVASIVE PROCEDURE TO INVESTIGATE THE CONNECTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE. THE FIELD REPRESENTATIVE LATER REPORTED THAT THE PHYSICIAN PLANNED TO CONTINUE TO MONITOR THE LEAD FOR NOW. THE PATIENT EXPERIENCED NO SYMPTOMS DUE TO THE LOSS OF CAPTURE, AND WAS SCHEDULED TO BE SEEN AGAIN THE FOLLOWING MONTH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CORONARY SINUS LEAD AND ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INTERMITTENT PACING IMPEDANCE MEASUREMENTS THAT WERE >2000 OHMS. LOSS OF CAPTURE WAS ALSO OBSERVED. THIS BEGAN IN AUGUST, AND THE MEASUREMENTS WERE NORMAL ON SOME DAYS AND OUT OF RANGE ON OTHER DAYS.

    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 68 YR 1488T| 4542| N119| 0185| H177