BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2777076 · Received October 9, 2012

    Report

    Report Number
    2124215-2012-10248
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    June 17, 2012
    Report Date
    July 20, 2012
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD WAS EXPLANTED. 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 HAD NORMAL PACING THRESHOLD MEASUREMENTS DURING A RECENT DEVICE CHANGE OUT PROCEDURE. APPROXIMATELY ONE MONTH LATER THE THRESHOLD MEASUREMENTS WERE 4.5V AT 0.4MS AND INTERMITTENTLY 5.0V AT 2.0MS. THE DEVICE WAS REPROGRAMMED VVI AND AS A RESULT THE PATIENT EXPERIENCED EDEMA SWELLING IN THE ANKLES AND ORTHOPNEA. THE DEVICE WAS THEN PROGRAMMED DDD. A REVISION PROCEDURE WAS PERFORMED. DURING THIS PROCEDURE THE RA LEAD DISLODGED. THE LEAD WAS UNSUCCESSFULLY REPOSITIONED AND A NEW RA LEAD WAS IMPLANTED AT THIS TIME. THERE WAS NO REPORT OF ADDITIONAL ADVERSE PATIENT EFFECTS.

    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 77 YR Hospitalization| L| R (B)(4)| 4086| 0184| (B)(4)