BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2910908 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16356
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS DISCARDED BY THE FACILITY AND THERE WILL BE NO RETURN OF PRODUCT. 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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. UPON REMOVAL, VISUAL OBSERVATION REVEALED THIS LEAD WAS DAMAGED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18675 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| R T177| 1793| 0144