BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 4232381 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19545
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE POST MARKET QUALITY ASSURANCE LABORATORY WILL ANALYZE THE DEVICE WHEN IT IS RETURNED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS AND LOSS OF CAPTURE AT MAXIMUM OUTPUTS. THE PHYSICIAN NOTED THAT THE AREA OF THE SUTURE SLEEVE APPEARED TO BE PINCHED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT DUE TO THE DAMAGED LEAD, THE PATIENT WAS REQUIRED FOR SURGERY. THE CAUSE WAS NOT CONCLUSIVELY DETERMINED. THE LV LEAD WAS EXPLANTED AND NO LONGER IN SERVICE WHILE THE CRT-D REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715783 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4542| 0158| 4136| N141| T175| 4543