BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1853540 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14985
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED AS THE PRODUCT WAS SURGICALLY CAPPED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS, NO CAPTURE AND LOSS OF SENSING. DURING THE LEAD REVISION PROCEDURE THE PRODUCT WAS TESTED EXTERNALLY AND THE CLINICAL OBSERVATIONS WERE STILL PRESENT. THE PHYSICIAN WAS UNABLE TO ASCERTAIN THE LOCATION OF THE FAILURE AND BELIEVES THAT THE LEAD WAS LIKELY FRACTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 4543| H177| E102| 1488T| MISMATCH| 0184