BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2173362 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11561
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    January 19, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATIONS AT THIS TIME ARE THAT THE LEAD MAY HAVE MIGRATED A LITTLE, THRESHOLDS HAVING RISEN TO 2.9 AT 1.0. THERE WAS NO ALLEGATION OF A DEVICE TO LEAD CONNECTION ISSUE, HOWEVER THE DEVICE HAD BEEN IMPLANTED ONE MONTH AT THE TIME OF THE ALLEGATION OF -OUT-OF-RANGE IMPEDANCE. TO DATE, INFORMATION SUGGESTS THAT THIS LV LEAD REMAINS IN SERVICE. AS NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT ONLY THE PROXIMAL SEGMENT WAS RETURNED AND THE LEAD WAS RETURNED SEVERED AT 65 MILLIMETERS. VISUAL INSPECTION FOUND DRIED BLOOD AND BODY FLUID IN THE LEAD LUMEN. A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED ON THE RETURN SEGMENT RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTION FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS WITH THE RETURNED SEGMENT. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS FROM THE RETURNED SEGMENT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECIEVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD DID EXHIBIT AN INTERMITTENT RISE IN PACE IMPEDANCE TO GREATER THAN 2000 OHMS. AT IMPLANT, THE LEAD IMPEDANCE WAS AT 1000 OHMS AND HAS GRADUALLY RISEN TO OUT OF RANGE. NO OVER SENSING WAS NOTED BUT ALSO THERE HAD BEEN NO PRESENTING ELECTROCARDIOGRAM (EGM) TO LOOK AT. THE PLAN WAS TO BRING THE PATIENT IN FOR TROUBLESHOOTING.

    Description of Event or Problem · 1

    THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND RETURNED FOLLOWING THE PATIENT'S DEATH. THERE WERE NO ALLEGATIONS RELATING TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4457| 1290| 4470| N119| 4542