BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2052155 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04018
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS CURRENTLY BEING ANALYZED BY THE POST MARKET QUALITY ASSURANCE LABORATORY. UPON COMPLETION OF THE ANALYSIS, THE REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE HELIX WAS RETRACTED AND DRIED BODY FLUID WAS IN THE HELIX HOUSING EXTENDING THROUGH THE LUMEN. DEFORMED CONDUCTOR COILS WERE NOTED 12.2 AND 13.0 CM FROM THE TERMINAL PIN WHICH WERE MOST LIKELY DUE TO THE SUTURE TIE DOWN. THE INSULATION WAS CUT 13.0 - 13.5 CM FROM THE TERMINAL PIN AND WAS MOST LIKELY DUE TO THE REMOVAL OF THE SUTURE SLEEVE. LEAD CONDUCTOR TESTING FOUND THE LEAD WAS ELECTRICALLY CONTINUOUS THEREFORE, THE OBSERVATION OF THE LEAD IMPEDANCE INCREASING OVER THE LAST YEAR WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE DEVICE REPLACEMENT PROCEDURE, THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE MEASUREMENTS. ANOTHER MANUFACTURES LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 81 YR 1298| 5076| S606| 4053| 4087