BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 4140454 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17233
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    June 15, 2009
    Report Date
    September 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCE OF GREATER THAN 2,000 OHMS NOTED DURING PREPARATION FOR DEVICE CHANGE. OTHER MEASUREMENTS WERE NORMAL EXCEPT THE THRESHOLDS WERE SLIGHTLY HIGH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED IMPEDANCE RANGE OF A UNIPOLAR LEAD AND DISCUSSED A POSSIBLE FRACTURE. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LV LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618782 EASYTRAK IMPLANTABLE LEAD LWS CPI - DEL CARIBE 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 1823| 4512| H229| 4464| 0125| 1241| 4453| H179