BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3212956 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10268
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 24, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION AND LABORATORY ANALYSIS CONFIRMED ALL COILS ARE FRACTURED APPROXIMATELY 43 CM FROM THE TERMINAL PIN, AREA OF SUTURE SLEEVE TIE-DOWN. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS NOT PROVIDING PACING THERAPY. A REVISION PROCEDURE WAS PERFORMED AND A LEAD FRACTURE WAS REVEALED. THE LEAD WAS EXPLANTED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312379 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization N118| 4518| T135| 4470| 0185