BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2172849 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10092
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT AN X-RAY REVEALED THAT THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED AND WAS LOCATED IN THE RIGHT VENTRICLE. A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS SUCCESSFULLY REPOSITIONED. NO FURTHER PATIENT ISSUES WERE 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 Required Intervention