BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2050613 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03421
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    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 ONE DAY POST IMPLANT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF SENSING AND CAPTURE AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POOR SENSING MEASUREMENTS AND INTERMITTENT CAPTURE. BOTH LEADS WERE FOUND TO BE DISLODGED. A LEAD REVISION PROCEDURE WAS SUCCESSFULLY PERFORMED. THE RA AND RV LEADS REMAIN IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R S603| 4087| 4088