BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2041843 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01072
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED. TWO SEGMENTS WERE RETURNED TOTALING A LENGTH OF 990 MM. THE ANODE RING TO TIP PART OF THE LEAD WAS MISSING. DRIED BLOOD AND BODILY FLUID WAS OBSERVED TO HAVE INFILTRATED THE LEAD LUMEN. THE CONDUCTOR COILS WERE DEFORMED AND STRETCHED CAUSING A FRACTURE. THE INSULATION WAS TORN AND EVIDENCE OF ELECTROCAUTERY DAMAGE WAS OBSERVED. LABORATORY TECHNICIANS NOTED THAT HANDMADE SUTURES SLEEVES WERE ALSO LOCATED ON THE LEAD. ANALYSIS WAS ABLE TO CONFIRM THE ALLEGATION THAT THE LEAD TIP BROKE OFF, THROUGH VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PROXIMAL PORTION OF THE LEAD HAS NOT BEEN RETURNED. SHOULD THIS LEAD GET RETURNED, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    THE LEAD HAS SINCE BEEN RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM WAS EXPLANTED DUE TO A PATIENT INFECTION. DURING THE PROCEDURE, THE TIP OF THE LEFT VENTRICULAR LEAD BROKE OFF. THE TIP REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 4054| 0181| N119| 4549| H210