MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Guidant notified physicians and patients of new safety information for
certain models of cardiac pacemakers manufactured between November 25, 1997
and October 26, 2000. A hermetic sealing component used in these devices may
experience a gradual degradation, resulting in a higher than normal moisture
content within the pacemaker case late in the device's service life. The
clinical behaviors associated with this failure mode can result in serious
health complications. Guidant has confirmed twenty reports of loss of pacing
output associated with this failure mode, including five patients
experiencing syncope. Loss of pacing output has also been associated with
reports of presyncope requiring hospitalization. Guidant has received two
reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart
failure may have developed in association with sustained high rate pacing.
Physicians should consider the unique needs of individual patients and the
specific technical recommendations set forth in the July 18, 2005 physician
communication. Guidant recommends that physicians consider replacing devices
for pacemaker-dependent patients and advises patients to seek medical
attention immediately if they notice shortness of breath, dizziness,
lightheadedness or a prolonged fast heart rate.

Read the complete MedWatch 2005 Safety summary, including a link to the firm
press release and the Guidant physician communication, at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#Guidant3


Stephen Miles Sacks, Ph.D.
Editor and Publisher
SCIPOLICY-The Journal of Science and Health Policy
Box 504, Haverford, PA 19041
Telephone: 610-660-0220
Fax: 610-660-0120
Website: http://Scipolicy.net
E-mail: editor@...
and
Owner/Moderator ResearchEvaluation-L Discussion Group
Owner/Moderator ThePayoff-L Discussion Group
Owner/Moderator Scipolicy-L Discussion Group
Owner/Moderator CounterTerrorism-L Discussion Group


[Non-text portions of this message have been removed]