ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc., (NYSE:STJ - News) announced today that it has developed a software upgrade that fully remedies a low-frequency anomaly in the software used in the APS III Model 3510 and Merlin PCS Model 3650 programmers.
In particular, when these tabletop programmers are used with certain models of Identity pacemakers, the anomaly in the programmer’s software may lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator status. The software anomaly does not affect the device’s actual battery voltage, longevity or functionality. The potentially affected Identity pacemakers are Models 5172, 5370, and 5376. No other St. Jude Medical device is affected.
St. Jude Medical has developed an upgrade for the software that can be used during routine device interrogation to fully remedy the matter and prevent it from occurring in the future. The Company will release this upgrade as soon as pending regulatory approvals are obtained.
The Company has not received any reports of patient deaths, adverse events or clinical complications as a result of the software anomaly. To date, the incidence rate of the anomaly is 0.027% (53 out of approximately 199,100 manufactured devices worldwide).
Following consultation with its independent, external Medical Advisory Board, the Company is taking a conservative approach in advising the medical community and regulatory agencies. A communication to patients as well as a full copy of the physician communication, which includes a description of the software anomaly, as well as St. Jude Medical’s recommendations to physicians for patient follow up, can be found at http://www.sjm.com/LowFrequencyAnomaly.aspx.
Overall reliability information about St. Jude Medical products can be found in the Company’s Product Performance Report on the St. Jude Medical web site at www.sjm.com.
St. Jude Medical has notified the U.S. Food and Drug Administration of this matter. The Company does not expect this matter to have any material financial impact.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 11,000 people worldwide. For more information, please visit www.sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, regulatory approvals, anticipated future product launches, revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company’s Quarterly Report on Form 10-Q filed on August 7, 2006 (see page 31 and Item 1A on page 32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Contact: St. Jude Medical, Inc., St. Paul Investor/Media Relations: Angela Craig, 651-481-7789
Source: St. Jude Medical, Inc.
