BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3212948 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10194
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS LESS THAN 100 OHMS, LOSS OF CAPTURE (LOC) AND ELECTROGRAM NOISE. THE PHYSICIAN PROGRAMMED THE DEVICE TO ATRIAL ONLY THERAPY AS THE PATIENT HAD AN UNDERLYING RHYTHM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313672 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR MISMATCH| 4469| S606| 1290| 1388T| 1388TC| 4087