CRM Product News is a monthly publication to create awareness regarding current product performance topics 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.
The FDA has recently classified portions of a communication from earlier this year as a Class II recall. Boston Scientific’s March 10, 2007 Product Update provided information that some ICD and CRT-D devices, typically implanted prior to July 2005 (column 1 of Table 1), may display replacement indicators during mid-life even though several months of battery voltage and capacity remain available for brady pacing and shock therapy. If ERI or EOL is triggered, device replacement should be scheduled. There have been no reports of patient injury related to this behavior, beyond device replacement. A model/serial number search tool is available at www.bostonscientific.com to determine if a device is subject to triggering ERI or EOL during mid-life at the projected rates shown in Column 1, Table 1 of the Product Update.
View the March 2007 Product Update:
ERI Charge Time Limit Extended During Mid-Life and Mid-Life Display of Replacements Indicators
A Closer Look articles provide educational/training information on a variety of topics to better understand the function of Boston Scientific Cardiac Rhythm Management (CRM) products. The following new articles are now available:
Smart Key Systems and Implantable Pacemakers and Defibrillators
Interpreting Electrogram Storage Initiated by Manual Threshold Testing in PDM and PDII Pacemakers
As part of our ongoing commitment to frequent, detailed publishing of product performance data, we announce the availability of the Q4 2007 CRM Product Performance Report. Data in this report are current as of October 5, 2007.
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Published November 27, 2007
