BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX

    MDR report key: 5846495 · Received August 4, 2016

    Report

    Report Number
    2124215-2016-11216
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    May 24, 2016
    Report Date
    August 20, 2020
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTB
    UDI-DI
    00802526265143
    PMA / PMN Number
    P960004/S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED VIA ASR ON REPORT ID # 2021791 IN Q3/2016 OF THE ASR REPORT SUBMITTED TO THE FDA ON #E2011006, WHICH WAS REVOKED ON 10/02/2017 FURTHER FOLLOW UP IS BEING PERFORMED TO OBTAIN ADDITIONAL INFORMATION. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. 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

    MANUFACTURER REPORT ID #2124215-2016-11216 CORRESPONDS TO THE INITIAL ASR REPORT SUBMITTED FOR EXEMPTION #E2011006. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED, AND THE RESULTS INDICATED A MOBILE MASS ATTACHED TO THE RIGHT VENTRICULAR (RV) LEAD, 2.4 CM X 0.9 CM IN THE SUPERIOR VENA CAVA REGION. THE SUSPECTED CAUSE WAS BEING CONSIDERED AS THROMBUS INFECTION. THE PATIENT WAS TO FOLLOW UP WITH CARDIOLOGY. THE SYSTEM REMAINS IN SERVICE. THE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501242 FINELINE II EZ STEROX IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC 4469 00802526265143

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Life Threatening