BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3771540 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-03810
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 3, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    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 THIS LEFT VENTRICULAR (LV) LEAD HAD LOSS OF CAPTURE DUE TO DISLODGEMENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED AND THE RA LEAD WAS CAPPED AND WAS SURGICALLY ABANDONED. THE LV LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248667 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 4470| 4542| H227| H179| 0148| N141| 4518| 5076