BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3043218 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01811
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    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 THIS RIGHT ATRIAL (RA) LEAD LEAD WAS FOUND TO EXHIBIT LOSS OF CAPTURE (LOC). THE LEAD WAS OBSERVED TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE LEAD WAS NOT TO BE RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147043 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4136| 4459| K173| 1296| 4087