BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3912937 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13475
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD SYSTEM EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2,000 OHMS. FURTHER, HEALTH CARE PROFESSIONAL (HCP) TESTED ALL CONFIGURATIONS AND GOT THE SAME RESULTS. THE NORMAL BRADYCARDIA PACING WAS PROGRAMMED OFF BUT THERE WAS STILL TACHYCARDIA DETECTION AND THERAPY NOTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS. ADDITIONAL INFORMATION RECEIVED THAT LEAD FRACTURE WAS SUSPECTED; HOWEVER, IT WAS NOT CONFIRMED THROUGH FLUOROSCOPY AOR X-RAY. THE PHYSICIAN WILL SEE HOW PATIENT DOES WITHOUT CRT PACING AND ALSO, LV FUNCTION WILL BE RECHECKED ON THE NEXT FOLLOW UP. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390662 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR H175| H179| 4471| 4518| 4470| 0185| 1290| N118