An interactive, web-based Q3 2009 CRM Product Performance Report is now available at bostonscientific.com/ppr. This report includes enhanced performance data for pacing, defibrillation, and heart failure lead products. This level of performance data meets or exceeds the industry standards developed by the AdvaMed CRM Working Group for uniform performance reporting. Performance data includes detailed malfunction categories, lead complication data, acute lead observations, and device survival probability data. Data in this report are current as of July 17, 2009.
Boston Scientific has determined that alert conditions for a limited subset of out-of-range Daily Measurements related to leads may not be recognized by Model 6476 (United States) or Model 6468 (Europe) LATITUDE in-home communicators. However, Daily Measurement values uploaded from the implanted defibrillator will be available from the ALL PATIENTS page after completion of the next full device interrogation, which occurs during Weekly Device Alert Interrogations and scheduled remote follow-ups.
Until this behavior is corrected, Boston Scientific will review weekly interrogation data collected by affected Model 6468 and 6476 Communicators and will contact you by phone or fax if any out-of-range Daily Measurements fail to display a corresponding Red or Yellow Alert on the LATITUDE Website
This advisory applies only to a subset (~20%) of active LATITUDE communicators, which are used to transfer memory information from the implanted device to a physician-accessible website. It does not involve the implanted defibrillator, lead system, or programmer.
elect this link for additional information regarding Missed Alerts from a subset of LATITUDE® in-home communicators (Sept 9, 2009) or contact your local Boston Scientific CRM representative, United States Technical Services at 1.800.CARDIAC (227.3422) or European Technical Services at +32 2 416 7222.
A Closer Look articles provide educational/training information on a variety of topics to better understand the function of Boston Scientific CRM products. Articles are now available at bostonscientific.com and bostonscientific-international.com (A4 format and translations, where available).
Published September 28, 2009
