BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2053225 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03765
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 1, 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS RIGHT ATRIAL (RA) LEAD, DEVELOPED A POCKET INFECTION. THE PATIENT WAS TREATED WITH MEDICATION. PATIENT IS FINE, AND ENTIRE SYSTEM REMAINS IMPLANTED. 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 MISMATCH| P163| 0158| 4096