An interactive, web-based Q3 2010 CRM Product Performance Report is now available at bostonscientific.com. Data in this report are current as of July 9, 2010.
Boston Scientific recently provided physicians with information regarding its CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE implantable defibrillators manufactured between January 2006 and November 2007. These devices include a component referred to as a "magnetic reed switch," designed to sense the presence of a magnet. In rare instances, application of a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch located within the device to become permanently stuck in a closed position and prevent delivery of programmed tachy therapy.
The affected devices are not sold today, and no devices in this population remain available for implant. A rate of one failure per 670 devices (0.0015) has been observed to date, and the probability of patient harm (therapy not available when needed due to a stuck magnetic reed switch) is estimated to be less that one in one million for a 60-month device service life. No patient deaths or injuries have been reported as a result of this issue, although some devices have been replaced. CRT-Ds and ICDs currently being distributed are not subject to this advisory.
Select this link for additional information regarding the July 2010 Magnetic Reed Switch product advisory 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.
Published August 13, 2010
