BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3040811 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01235
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2012
    Report Date
    November 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION INDICATED THAT BODY FLUID WAS NOTED IN THE ENTIRE LEAD LUMEN. THE FIELD ALLEGATION OF LOW INTRINSIC AMPLITUDE AND HIGH OUT-OF-RANGE PACING IMPEDANCE WERE NOT CONFIRMED BY VISUAL INSPECTION AND ELECTRICAL TESTING. THE LEAD WAS SEVERED AND ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED.

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS SEEN DUE TO HIGH THRESHOLD MEASUREMENTS OF 5 VOLTS AT .2 MILLISECONDS. THERE WAS ALSO MUSCLE STIMULATION AND NO CAPTURE IN ANY OTHER VECTORS. THE LEAD WAS PROGRAMMED OFF. IT WAS NOTED THAT THE PHYSICIAN WANTED TO REPLACE OR REPOSITION THE LEAD; HOWEVER, THE PATIENT DECLINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ALMOST TWO YEARS LATER, THIS LEAD WAS PARTIALLY ABANDONED DUE TO PATIENT¿S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW INTRINSIC AMPLITUDE AND PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THE HEALTH CARE PROFESSIONAL (HCP) INDICATED THEY WISHED NOT TO RECEIVE ANY MORE YELLOW ALERTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT PROGRAMMING THE LV LEAD DAILY MEASUREMENTS OFF WOULD ELIMINATE THE YELLOW ALERTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142675 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR H175| 0175| 4518| 4470| N118