BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 6705502 · Received July 12, 2017

    Report

    Report Number
    2124215-2017-10248
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    March 22, 2017
    Report Date
    June 28, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED A COMPLETE LEAD WITH SET SCREW MARKS ON THE TERMINAL PIN. HELIX WAS STRETCHED AND BENT WITH ENTWINED TISSUE. DETAILED ANALYSIS ILLUSTRATED INSULATION DAMAGE APPROXIMATELY 192-203 MM FROM THE TERMINAL PIN, ON OPPOSING SIDES. MICROSCOPIC ANALYSIS INDICATES THE FORMATION OF HOLES IN THE TUBING WALL WHICH WERE CAUSED BY EXTERNAL FORCES EXERTED ON THE LEAD BODY WHICH TRANSFERRED PRESSURE TO THE UNDERLYING COIL WINDINGS, CAUSING A BREAKDOWN OF THE INSULATION. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. IN THIS CASE, WE BELIEVE THE STRESS WAS THE RESULT OF CLAVICULAR/FIRST-RIB ENTRAPMENT. THE REPORTED LOSS OF CAPTURE, WAS LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD PRESENTED FOR A ROUTINE FOLLOW-UP, AT WHICH TIME POOR SENSING AND LOSS OF CAPTURE WERE EXHIBITED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPLACED IN ABSENCE OF ADVERSE PATIENT EFFECTS. THE LEAD IS INTENDED TO BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486532 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4088| 4471