BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2910245 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15284
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    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 FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, 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, THIS RIGHT ATRIAL LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED SUCCESSFULLY, HOWEVER SHORTLY AFTER THE REVISION PROCEDURE A DISLODGMENT OCCURRED AGAIN. A SECOND PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17580 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R