BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3052747 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04987
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ROUTINE DEVICE INTERROGATION HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WITH NOISE WERE NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE NOISE WAS REPRODUCIBLE WITH ARM MOVEMENTS. FARFIELD OVERSENSING WAS ALSO OBSERVED ON THE ATRIAL CHANNEL. THE PHYSICIAN PLANNED TO DISCUSS THE SITUATION WITH THE IMPLANTING PHYSICIAN. THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION REGARDING THE STATUS OF THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155592 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR H175| 0157| 4087| 4513| N118