BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3210318 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08314
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    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 AND COMPETITOR RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC). THE PATIENT WAS SEEN IN THE HOSPITAL WITH HEART FAILURE, WHERE THE DEVICE WAS FOUND TO BE CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI) BASED ON MONITORING VOLTAGE. AN ELECTROGRAM (EGM) WAS TAKEN WHICH LOOKS FLAT AND THERE WERE NO EPISODES FOUND IN THE LOGBOOK. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE DEVICE AND LEADS REMAIN IN SERVICE AT THIS TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311834 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR MISMATCH| 1580| 4517| 1488T| M155| H215