BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3922029 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12301
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    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 LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENT OF GREATER THAN 2,000 OHMS. FLUOROSCOPIC IMAGING CONFIRMED THAT THIS LEAD WAS FRACTURED. SUBSEQUENTLY, THE LEAD WAS TESTED ON A PACING SYSTEM ANALYZER (PSA) AND AN OUT OF RANGE MEASUREMENT OF 3,000 OHMS WAS OBTAINED. NO CONNECTION ISSUE WAS NOTED. THIS LEAD WAS SURGICALLY ABANDONED AND NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401617 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4517| 4470| H179| N164| N161| 0184| 4592