BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3930015 · Received July 11, 2014

    Report

    Report Number
    2124215-2014-13783
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WAS NO LONGER IN SERVICE. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE THAT THIS LV LEAD WAS DISLODGED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE THAT LEAD DISLODGEMENT WAS CONFIRMED BY MEANS OF FLUOROSCOPY. THIS LV LEAD WAS EXPLANTED AND WOULD NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407195 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 0184| 4469| 4542| 4554| N119