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.
On January 4, 2008, Boston Scientific provided physicians with updated product
performance information related to a May 12, 2006 Product Advisory. Repetitive mechanical stress applied to
the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices when
implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a
subpectoral position with the serial number facing away from the ribs are not included in this advisory.
Further clinical experience and testing indicate that VITALITY extended life models are also subject to this
failure mechanism if implanted in a susceptible orientation. Standard life Vitality devices are not included
in this advisory (one observation of this type in over 125,000 devices implanted to date).
There have been no reported patient deaths associated with this issue. A model/serial number search tool is
available at www.bostonscientific.com to determine if a device is subject to malfunction if implanted in a
usceptible orientation.
View the January 4, 2008 Advisory Update physician letter:
Physician Letter
View the January 4, 2008 Advisory Update patient letter:
Patient Letter
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:
Cellular Phones and Implantable Devices
Understanding the Safety Switch Feature
Understanding Latex, PVC, and Implantable Device Systems
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Published January 22, 2008
