BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2042400 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01278
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE LEAD WAS DISPOSED OF BY THE HOSPITAL STAFF BEFORE IT COULD BE RETRIEVED FOR RETURN. 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 THE PATIENT IMPLANTED WITH THIS IMPLANTABLE RIGHT ATRIAL PACING LEAD HAD FALLEN. A CHANGE IN THE DAILY PACING IMPEDANCE AND SENSING MEASUREMENTS THEN OCCURRED. A CHEST X-RAY REVEALED THE LEAD HAD DISLODGED INTO THE SUPERIOR VENA CAVA. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. 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 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 4086| 4087| S603