BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3212442 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08546
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    February 12, 2014
    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

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING A REVISION PROCEDURE WAS PERFORMED AND THIS LV LEAD WAS REMOVED FROM SERVICE AND REPLACED. THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED WITH A SHOOTING PAIN ACROSS HER CHEST. SYSTEM EVALUATION SHOWED THIS LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS WITH NO CAPTURE AT MAXIMUM DEVICE OUTPUTS. THE LEAD WAS REPROGRAMMED FROM LV TIP TO RIGHT VENTRICULAR (RV) COIL FOR PACING AND LV TIP TO LV RING FOR SENSING WHICH PRODUCED GOOD IMPEDANCE AND THRESHOLD MEASUREMENTS. SENSING MEASUREMENTS HAD ALWAYS BEEN WITHIN NORMAL LIMITS. THE PATIENT WILL CONTINUE TO BE MONITORED. NO 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
    312823 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 0184| H210| 4543| N161| 4469