BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3921752 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12194
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENT ABOVE 2,000 OHMS IN ALL VECTORS ALONG WITH NO CAPTURE AT MAXIMUM OUTPUT. IT WAS NOTED THAT THIS LV LEAD WAS TURNED OFF DUE TO A FRACTURE BUT WAS NOT CONCLUSIVELY VERIFIED. FURTHER, LV LEAD DAILY MEASUREMENTS WERE TURNED OFF AS PATIENT COULD FEEL THE IMPEDANCE TESTING ON LV DAILY. THIS LEAD WAS SURGICALLY ABANDONED AND WAS REPLACED WITH AN EPICARDIAL LEAD. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399519 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 0185| 4470| N118| H175| 4518