BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2173653 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11057
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RA LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION THAT THIS RA LEAD WAS SURGICALLY ABANDONED. THERE IS NO INTENDED RETURN OF THIS PRODUCT. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS RIGHT ATRIAL (RA) LEAD, DEVELOPED A FEVER, LEUKOCYTOSIS, AND A (B)(6). ANTIBIOTICS WERE GIVEN TO THE PATIENT TO TREAT THE (B)(6) INFECTION. THIS WAS SUSPECTED TO BE DUE TO PATIENT CONDITION, AND NOT RELATED TO DEVICE MALFUNCTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1