BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950533 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22583
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 14, 2010
    Report Date
    November 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN X-RAY WAS PERFORMED AND THERE WERE NO ISSUES IDENTIFIED WITH THE LEAD. NO FURTHER EVALUATION IS PLANNED AT THIS TIME. THE PATIENT WILL BE MONITORED VIA LATITUDE. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS ISSUED FOR THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD INDICATING HIGH SHOCK IMPEDANCE. SHOCK IMPEDANCE WAS 87 OHMS AT THE LAST IN OFFICE CHECK. TECHNICAL SERVICES (TS) DISCUSSED HOW SHOCK IMPEDANCE HAD BEEN VARIABLE AND EVEN THOUGH IMPEDANCE WAS WITHIN RANGE AT THE LAST IN OFFICE CHECK, THE INTEGRITY OF THE SYSTEM WAS NOW IN QUESTION. NOISE WAS NOT PRESENT ON ANY OF THE CHANNELS. THERE WERE NO RECENT EPISODES WITH SHOCKS DELIVERED AND THERE HAD ONLY BEEN TWO SHOCKS DELIVERED IN THE HISTORY OF THIS DEVICE. TS DISCUSSED GETTING AN X-RAY VS. DELIVERING A 1.1 JOULE AND MAXIMUM ENERGY SHOCK TO TEST THE INTEGRITY OF THE SYSTEM. THE CALLER WILL DISCUSS THE RECOMMENDATIONS WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4555| 0181| N119| 4135| 4137