MINN. (St. Paul)--Notification of Potential for Malfunction in Pacemakersgreenspun.com : LUSENET : Grassroots Information Coordination Center (GICC) : One Thread
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ST. JUDE MEDICAL NOTIFYING PHYSICIANS OF POTENTIAL FOR MALFUNCTION IN SMALL NUMBER OF TRILOGY PACEMAKERS
Story Filed: Friday, March 10
ST. PAUL, Minn., Mar 10, 2000 /PRNewswire via COMTEX/ -- St. Jude Medical, Inc. (NYSE: STJ) announced today it is notifying physicians that a microprocessor anomaly can lead to a malfunction in a very small number of its Trilogy(R) family of pacemakers. This voluntary notification is an update to a July 1999 physician communication on Trilogy(R) pacemakers. There have been no reported patient injuries associated with this situation. The Company is recommending that normal patient monitoring continue for Trilogy(R) patients, with particular attention to pacemaker dependent patients. The voluntary notification does not impact Trilogy(R) pacemakers shipped after early 1999 or other St. Jude Medical pacemaker or ICD products. The financial impact of this notification is not material to St. Jude Medical.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000101/JUDELOGO ) Approximately 20 devices out of a total population of approximately 144, 000, or 0.014% (fourteen thousandths of one percent), have been reported to exhibit an inappropriate pacing mode change to single-chamber atrial pacing. The Company estimates a similar number of Trilogy(R) devices could exhibit a pacing mode change in the future. Overall, the demonstrated reliability of the Trilogy(R) family is in excess of 99%, which exceeds its design specification and is comparable to published pacemaker industry data.
Commenting on the Trilogy(R) physician communication, Daniel J. Starks, President and CEO of the St. Jude Medical Cardiac Rhythm Management Division, said, "This voluntary notification relates to an extremely low incidence of Trilogy(R) microprocessor anomalies that can impact system performance. The number of patients potentially affected is extremely small. In fact, we believe the clinical risk associated with pacemaker replacement is higher in most instances than the risk of Trilogy(R) device malfunction. Overall, the Trilogy(R) system is performing better than its design specification. However, after consultation with our Medical Advisory Board and regulatory agencies, we concluded that a complete disclosure to our clinician customers was appropriate for the management of patients with Trilogy(R) pacemakers. Patient safety is always our number one priority, regardless of level of potential risk with these sophisticated, life saving and enhancing medical devices."
Dr. Bruce Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic Foundation in Cleveland, Ohio, and a member of the Company's Medical Advisory Board, said, "This notification provides physicians the information they need to properly manage patients. Patients with Trilogy(R) pacemaker should not be overly concerned. If they have questions, they should contact their physician. St. Jude Medical is taking the correct approach with this clinician notification, even though the rate of device malfunction is extremely low."
Any statements made regarding the Company's anticipated revenues, earnings and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Company's Annual Report on Form 10-K for the year ended December 31, 1998 (see pages 28-29). Actual results may differ materially from anticipated results.
St. Jude Medical, Inc. ( http://www.sjm.com ) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.
SOURCE St. Jude Medical, Inc. (C) 2000 PR Newswire. All rights reserved. http://www.prnewswire.com
CONTACT: Laura Merriam, Investor Relations, 651-766-3029, or Peter Gove, Media Relations, 651-481-7790, both of St. Jude Medical, Inc.
-- (Dee360Degree@aol.com), March 11, 2000
Thanks, Dee. This is very important news! Also see related articles on this board:
"Company Warns Doctors of Possible Pacemaker Problem"
"Pacemaker programmers, reminder to verify date/time"
-- Lee Maloney (email@example.com), March 11, 2000.
Thank you for the additional links. I appreciate all of your great posts and hard work.
Best wishes, Dee
-- (Dee360Degree@aol.com), March 11, 2000.