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St Jude recall (programming only)


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  • St Jude recall (programming only)

    St. Jude Medical Announces ICD Software Upgrade Notification to Physician Customers
    ST. PAUL, Minn.--(BUSINESS WIRE)--June 20, 2005--St. Jude Medical, Inc. (NYSE:STJ) announced today that it has notified physicians that certain of its implantable cardioverter defibrillators (ICDs) are in need of a non-invasive, 45-second software upgrade to correct two anomalies found during routine product evaluation.

    The anomalies do not pose a significant risk to patients and the Company has not received any reports of patient adverse events or clinical complications as a result of the anomalies. In addition to notifying its customers, St. Jude Medical is today providing physicians with a simple software tool to correct the issues via its programmer. The Company, in consultation with a group of consulting physicians, has recommended that this be done at the patient's next routine follow-up visit or at the physician's discretion.

    The two issues are described below:

    The Company discovered during examination of a single returned device that it could be possible when a device's battery voltage is past mid-life and approaching its Elective Replacement Indicator (ERI), for a charging cycle to be skipped as the device attempts to deliver multiple shocks in rapid succession. If this were to occur, the first shock would always be delivered by the device as programmed. A subsequent shock in the sequence could be delivered after a two to four second delay, but the anomaly could cause the device to have fewer than the maximum total of six therapeutic shocks available for a single diagnosed episode as called for in the product's labeling. There have been no reports of any patient adverse events or clinical complications.

    The second anomaly in some devices is an electrical "noise" generated as a result of the charging of the device's high-voltage capacitors (tracked back to a component supplied by one vendor). The "noise" in the capacitor can be interpreted by the device's sensors as activity if programmed on, causing a temporary increase in the pacing rate. Again, each of the devices has a safe maximum pacing rate set by the patient's physician, and the Company has not received any reports of patient adverse events or clinical complications.

    "As a member of St. Jude Medical's advisory group reviewing these issues, I am confident that the Company has taken the appropriate proactive steps in resolving the anomalies in the best interest of patients," said Dr. Bruce Wilkoff, director of cardiac pacing and tachyarrhythmia devices at The Cleveland Clinic Heart Center.

    There are approximately 39,000 Epic(TM) and Atlas(R) devices implanted worldwide that are subject to one or the other software upgrade.

    St. Jude Medical has worked actively with the U.S. Food and Drug Administration (FDA) in approving the software upgrade and in developing an implementation plan, in consultation with a physician advisory panel, to proactively issue the voluntary notification. The software upgrade was approved by the FDA on Friday, June 17, and has already been sent to physician customers.

    The Company does not expect this advisory to have any material financial impact.

    Note to editors: A programmer is a special tabletop computer that enables a physician to communicate non-invasively with a patient's implanted device. A telemetry wand is placed on the patient's chest and the programmer will automatically detect the affected ICDs and download the new software to the device. This process should take about 45 seconds.

    St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value.

    Any statements made regarding the Company's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2004 (see page 16). Actual results may differ materially from anticipated results.

    CONTACT: St. Jude Medical, Inc., St. Paul
    Investor Relations:
    Laura Merriam, 651-766-3029
    Media Relations:
    Angela Craig, 651-481-7789
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

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