BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 4131719 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14665
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LV LEAD WILL NOT 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 HAS EXHIBITED A HIGH PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS SOMETIME IN THE PAST YEAR. THE LV LEAD WAS SUSPECTED TO HAVE BEEN FRACTURED. SURGICAL INTERVENTION WAS PERFORMED AND THE LV LEAD WAS TESTED WITH A PACING SYSTEM ANALYZER WHERE IT DISPLAYED AN IMPEDANCE MEASUREMENT OF GREATER THAN 4000 OHMS. THE LV LEAD WAS EXPLANTED BUT ADDITIONAL INFORMATION MADE AVAILABLE FROM THE FIELD INDICATED THAT APPROXIMATELY TWO CENTIMETERS OF THE LEAD REMAINS UNCAPPED IN THE SUPERIOR VENA CAVA AS IT WAS TOO DIFFICULT TO REMOVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613186 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R M170| N163| 4480| 0148| 4542