BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140552 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16936
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    April 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE PHYSICIAN BELIEVES THAT THE FLUCTUATIONS ARE RELATED TO THE PATIENT'S HEART DISEASE. THE PATIENT HAD PREVIOUSLY BEEN HOSPITALIZED FOR HEART FAILURE AND THERE WAS A RELATED OUT OF RANGE MEASUREMENT. A SAVE ALL TO DISK WAS PERFORMED AND THERE WERE NO EPISODES OF OVERSENSING AND THE OTHER PACING PARAMETERS WERE WITHIN NORMAL LIMITS. THE SHOCK IMPEDANCE TREND AVERAGED AROUND 80-90 OHMS. THE PHYSICIAN PLAN TO CONTINUE TO MONITOR THIS PATIENT VIA THE REMOTE HOME MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618277 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4542| P162| 0293| 5594