BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3210913 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09874
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    March 5, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS CONFIRMED TO BE FRACTURED 436 MILLIMETERS (MM) FROM THE LEAD TIP. BASED ON THE ANALYSIS RESULTS, WE SUSPECT THAT FATIGUE OR STRESS IN THE REGION OF THE FRACTURE SITE DUE TO RELATIVE MOTION BETWEEN THE SUTURE SLEEVE AND AN ANATOMICAL FEATURE LED TO THE FRACTURE. AS A LEAD MOVES IN RESPONSE TO NORMAL HEART RHYTHMS AND BLOOD FLOW, EXTENSIVE FLEXING OVER A PERIOD OF TIME MAY CAUSE FATIGUE OR STRESS, WEAKENING THE COIL, ULTIMATELY RESULTING IN A FRACTURE. THIS CAN OCCUR BETWEEN THE SUTURE SLEEVE AND SOME OTHER PART OF THE ANATOMY. FATIGUE FRACTURES IN THE POCKET OR CLAVICULAR/FIRST RIB AREA ARE WELL KNOWN AND DOCUMENTED IN THE INDUSTRY. A COMBINATION OF LEAD DESIGN, IMPLANT TECHNIQUES, AND PATIENT ANATOMY AND ACTIVITY LEVEL CONTRIBUTE TO THESE TYPES OF OCCURRENCES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, A CHECK LEFT VENTRICULAR (LV) LEAD MESSAGE WAS OBSERVED DUE TO A LOW INTRINSIC AMPLITUDE MEASUREMENT LESS THAN 3.0 MILLIVOLTS (MV). ADDITIONALLY, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION AND THE LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS RANGING FROM 1,000 TO 3,000 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING AND PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LV LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CONTINUE TO EXHIBIT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE PROGRAMMED LEAD CONFIGURATION WAS CHANGED TO RING TO CAN AND PACING IMPEDANCE MEASUREMENTS WERE NOTED TO BE 1,000 OHMS. THE PHYSICIAN WILL CONTINUE MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN X-RAY WAS PERFORMED AND REVEALED A LEAD FRACTURE. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310389 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1170| N119| 4285| 4135| 1823| 0157| 0185| H229| 4512| 4543| H175