Boston Scientific Logo

CRM Product News

May 2010
CRM Product News is a monthly publication to create awareness regarding current product performance news and to highlight new information included in the quarterly CRM Product Performance Report (PPR). Topical summaries and links to comprehensive source information are listed below.

Now Available: Q2 2010 CRM Product Performance Report (PPR)

An interactive, web-based Q2 2010 CRM Product Performance Report is now available at bostonscientific.com. Data in this report are current as of April 9, 2010.


U.S. distribution of all CRT-D and ICD devices has resumed

Boston Scientific has received U.S. Food and Drug Administration clearance for manufacturing changes to its LIVIAN™ and RENEWAL® cardiac resynchronization therapy defibrillators (CRT-Ds) and CONFIENT™, PRIZM™ and VITALITY™ implantable cardioverter defibrillators (ICDs) and has resumed U.S. distribution of these products. The Company has now resumed U.S. distribution of all its CRT-D and ICD devices.


Canada Product Advisory - Canada ALTRUA Nominal Settings, 05-May-10

Boston Scientific has determined that approximately 400 ALTRUA devices were distributed in Canada with Lead Configuration programmed to a factory nominal value of unipolar even though package labeling and Instructions for Use state that the nominal value is bipolar.


This advisory is limited to ALTRUA pacemakers distributed in Canada. No geographies other than Canada are affected by this advisory.


Select this link for additional information regarding Canada ALTRUA Nominal Settings 05-May-10, or contact your local Boston Scientific CRM representative or Technical Services at 1.800.CARDIAC (227.3422).


New Educational Materials

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).


Calibration of the LATITUDE Digital Blood Pressure Monitor (Category: LATITUDE)



Published May 25, 2010