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.
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.
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).
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 May 25, 2010
