BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1951485 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23051
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    June 1, 2010
    Report Date
    November 26, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS HOSPITALIZED AND TREATED FOR THE EFFUSION. THIS LEAD STILL REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED SHORTNESS OF BREATH AND A PLEURAL EFFUSION. IT IS UNKNOWN IF THE EFFUSION WAS A RESULT OF THE IMPLANTATION PROCESS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R