BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1950898 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22819
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THIS LOCAL REPRESNETATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY DUE TO RIGHT ATRIAL (RA) LEAD DISLODGEMENT. THE RA LEAD WAS SUCCESSFULLY REPOSITION AND NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. ALL DIAGNOSTIC LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO FURTHER INTERVENTION WAS UNDERTAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R