BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 1771605 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13540
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED AND THE PATIENT WILL BE FOLLOWED IN THREE WEEKS FOR THE ADDITIONAL TESTING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ATRIAL LEAD DISPLAYED NOISE WHICH RESULTED IN POSSIBLE CROSSTALK AND IN THE STORAGE OF VENTRICULAR TACHYCARDIA EPISODES. THE P WAVE MEASUREMENTS WERE LOW. A TECHNICAL SERVICE CONSULTANT REVIEWED AN ELECTROGRAM AND SUSPECTED AN ATRIAL LEAD ISSUE OR LOSS OF CAPTURE. THE PATIENT HAD BEEN EXERCISING ON AN ELLIPTICAL TRAINER AND THE FIELD REPRESENTATIVE BELIEVED THAT THE LEAD MAY HAVE DISLODGED OR FRACTURED. THE TECHNICAL SERVICE CONSULTANT SUGGESTED ADDITIONAL TESTING OF THE LEAD WITH MANIPULATION.

    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 64 YR 4469| 4086| 4470| 1297