BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2052029 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03991
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS HOSPITALIZED AFTER EXPERIENCING SYNCOPE. IT WAS NOTED THAT THIS PATIENT HAD A 12 SECOND PAUSE IN PACING. PATIENT ISOMETRICS AND MANIPULATIONS WERE PERFORMED, AND THE LOSS OF CAPTURE/LOSS OF PACING COULD NOT BE RECREATED. IT WAS FURTHER NOTED THAT WHEN THE LV LEAD WAS PROGRAMMED OFF, GOOD RV PACING AND CAPTURE WERE OBSERVED. ALL OTHER LEAD MEASUREMENTS WERE NOTED TO BE NORMAL. TECHNICAL SERVICES (TS) DISCUSSED THAT IT WAS UNKNOWN AT THIS TIME WHAT CAUSED THE REPORTED ASYSTOLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LV IMPEDANCES WERE GREATER THAN 2,000 OHMS. THE LV LEAD WAS SUBSEQUENTLY PROGRAMMED OFF. IT WAS NOTED THAT THE LV LEAD WOULD BE REPLACED WHEN THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening 1861| T127| 4543| H210| 0148| 4549| 4017