BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2171579 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09727
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DURING A FOLLOW-UP, IT WAS NOTED THAT THIS RIGHT ATRIAL LEAD EXHIBITED A HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENT AND AN ELEVATED THRESHOLD MEASUREMENT. A REVISION PROCEDURE WAS DONE. DURING THE PROCEDURE, THE PHYSICIAN DISCONNECTED THE LEADS FROM THE DEVICE AND RECONNECTED THEM, AND MEASUREMENTS WERE WITHIN NORMAL RANGE. THIS LEAD WAS FOUND TO BE STRETCHED, SO THE PHYSICIAN MOVED IT AND THE MEASUREMENTS WERE THE SAME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 0181| 4096| F110