BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3040657 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00721
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS CONFIRMED TO BE FRACTURED 455 MM FROM THE TERMINAL PIN. BASED ON THE ANALYSIS RESULTS, WE SUSPECT THAT FATIGUE OR STRESS IN THE REGION OF THE FRACTURE SITE DUE TO RELATIVE MOTION BETWEEN THE SUTURE SLEEVE AND AN ANATOMICAL FEATURE LED TO THE FRACTURE. AS A LEAD MOVES IN RESPONSE TO NORMAL HEART RHYTHMS AND BLOOD FLOW, EXTENSIVE FLEXING OVER A PERIOD OF TIME MAY CAUSE FATIGUE OR STRESS, WEAKENING THE COIL, ULTIMATELY RESULTING IN A FRACTURE. THIS CAN OCCUR BETWEEN THE SUTURE SLEEVE AND SOME OTHER PART OF THE ANATOMY. FATIGUE FRACTURES IN THE POCKET OR CLAVICULAR/FIRST RIB AREA ARE WELL KNOWN AND DOCUMENTED IN THE INDUSTRY. A COMBINATION OF LEAD DESIGN, IMPLANT TECHNIQUES, AND PATIENT ANATOMY AND ACTIVITY LEVEL CONTRIBUTE TO THESE TYPES OF OCCURRENCES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD WAS ADMITTED TO THE HOSPITAL DUE TO HEART FAILURE EXACERBATION. INTERROGATION OF THE DEVICE REVEALED HIGH OUT OF RANGE LV PACING IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE. IT WAS FOUND THE LEAD HAD FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY EXPLANTED. DURING THE PROCEDURE A BEND IN THE LEAD WAS NOTED 1 CENTIMETER (CM) FROM THE SUTURE SLEEVE. IT WAS REPORTED THE DEVICE HAD MIGRATED WHICH CAUSED THE BEND IN THE LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143617 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 1298| 6033| T 83F| (B)(4)| 4469| 4543| 4470| H120