BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2905437 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13378
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 30, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NORMAL FOLLOW UP HAS BEEN SCHEDULED, AND THE DEVICE WAS PROGRAMMED TO ENSURE CAPTURE.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEFT VENTRICULAR LEAD WAS DEACTIVATED. THE PATIENT HAD EXPERIENCED SHORTNESS OF BREATH. A DECISION WILL BE MADE ABOUT THE REPLACEMENT PROCEDURE OF THIS LEAD DURING A FUTURE DEVICE REPLACEMENT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHEN TECHNICAL SERVICES WAS REVIEWING ANOTHER ISSUE WHEN IT COMES TO THE DEVICE OUT OF RANGE PACING IMPEDANCES WERE NOTED ON THE LEFT VENTRICULAR LEAD. THE LEAD IMPEDANCES HAVE PLATEAUED TO NORMAL VALUES. AT THIS TIME THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11855 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 1861| 4517| M175| 4087| 0155| H195