BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3043235 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03042
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD CONFIRMED THAT THE DISTAL TIP WAS BENT AT A 30-DEGREE ANGLE BETWEEN THE HELIX HOUSING AND ELECTRODE RING. RESISTANCE AND PRESSURE TESTING WAS THEN PERFORMED ON THE LEAD, VERIFYING THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. ANALYSIS CONFIRMED THE BENT LEAD TIP.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IMPLANT PROCEDURE, THIS LEAD DISPLAYED POOR SENSING AND NO CAPTURE IN MULTIPLE LOCATIONS IN THE ATRIUM. THE PHYSICIAN WAS NOT CONFIDENT IN THE INTEGRITY OF THE LEAD, THEREFORE, EXPLANTED THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146727 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4086| 4136| K173