BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2908333 · Received January 10, 2013

    Report

    Report Number
    2124215-2012-14180
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    August 25, 2012
    Report Date
    October 15, 2012
    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 THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCES FROM THE 900 OHM RANGE TO 1840 OHMS. THERE WAS ONE OUT OF RANGE MEASUREMENT OF GREATER THAN 2,000 OHMS. THE IMPEDANCES THEREAFTER HAVE BEEN BACK INTO THE 800-900 OHM RANGE. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR EVALUATION. NO NOISE WAS ABLE TO BE REPRODUCED DURING MANIPULATION. THE IMPEDANCES DURING MANIPULATION WAS 955 OHMS. THE PATIENT'S PACING THRESHOLDS HAD INCREASED TO 4.5 VOLTS THEREFORE THE LEAD CONFIGURATION WAS CHANGED AND TROUBLESHOOTING WAS AGAIN PERFORMED IN THE NEW CONFIGURATION WITH NO OUT OF RANGE MEASUREMENTS BEING ABLE TO BE PRODUCED. AT THIS TIME, NO FURTHER INTERVENTION HAS BEEN PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14776 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 4518| 0184| N118| 1888TC