BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1876327 · Received October 20, 2010

    Report

    Report Number
    2124215-2010-18665
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 20, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    TWO LEAD SEGMENTS WERE RECEIVED IN OUR (B)(4) LABORATORY WITH BOTH THE OUTER AND INNER COILS FRACTURED AT 260 MILLIMETERS (MM). SLIGHT DEFORMATION/KINKS IN THE OUTER INSULATION AND WEAR TO THE INNER INSULATION WERE OBSERVED AT 243, 247 AND 257 MM. A KINK IN THE OUTER INSULATION WAS OBSERVED AT THE 260 MM FRACTURE SITE WITH THE INSULATION ENDING AT 265 MM. X-RAY EXAMINATION REVEALED THAT THE PROXIMAL OUTER COIL WIRE HAD A SECONDARY FRACTURE CREATING A SHORT WIRE SEGMENT WHICH REMAINED ATTACHED BY THE INSULATION. DUE TO THE RETURNED CONDITION OF THE LEAD, ROUTINE MECHANICAL AND ELECTRICAL TESTING WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    \\

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHANGEOUT PROCEDURE, THIS LEFT VENTRICULAR (LV) LEAD WAS OBSERVED TO BE FRACTURED SECONDARY TO POOL SLACK PLACEMENT IN THE POCKET. A NEW LV LEAD WAS IMPLANTED WITHOUT COMPLICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION. THE LEAD WAS TO BE RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R 4088| 4543| 1860| 4548| H210| N119| 0157| 4470