BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3211439 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08291
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO RETURN OF PRODUCT IS INTENDED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHORTLY AFTER IMPLANT, IT WAS NOTED THIS ATRIAL LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED. IT WAS NOTED THIS LEAD HAD PULLED BACK OUT OF THE VENOUS SYSTEM. THE LEAD HAD BEEN SECURED WITH THE SLEEVE AND REMAINING SUTURE. THE LEAD WAS REMOVED, REPLACED AND DISCARDED BY THE FACILITY. ACCEPTABLE MEASUREMENTS WERE OBTAINED WITH THE REPLACEMENT LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309188 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R