BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2173879 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10734
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT A CHEST X-RAY CONFIRMED THAT THIS RIGHT ATRIAL LEAD HAD DISLODGED. NORMAL SENSING WAS SEEN ON THE ATRIAL LEAD BUT LOSS OF CAPTURE WAS NOTED. THE DEVICE WAS REPROGRAMMED TO USE ONLY ATRIAL SENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1