Guidant Notifies Physicians Regarding Ventak 1861 PRIZM 2 DR Implantable Defibrillator.INDIANAPOLIS -- Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ) initiated a communication to physicians regarding the clinical performance of its VENTAK PRIZM PRIZM Potential Rating Index for Zip Marketers (Claritas, Inc.) PRIZM Primal Zoo Machine (band) (R) 2 DR Model 1861 implantable defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a . There have been 26 reports of failure including one recent death. Approximately 24,000 of these devices are currently implanted worldwide. In its May 23, 2005, letter to physicians, the company describes a rare failure that results in the device's inability to deliver therapy. The problem is in Guidant's VENTAK PRIZM 2 DR implantable defibrillators manufactured prior to November 2002. Devices manufactured after this date are not affected. Any patient with a VENTAK PRIZM 2 DR should consult with their physician if they have questions regarding their device, particularly if they have recently received a defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. shock. Guidant recommends that physicians continue monitoring patients every three months as described in the labeling. Guidant does not recommend early replacement of these devices. The overall device reliability remains high. Guidant has worked with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) on this communication and Guidant will continue working with the FDA on this issue, including any subsequent communication that may be helpful for patients or physicians. As a leading manufacturer of lifesaving technology, Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients. In addition to public regulatory reporting and periodic product performance publications, the company will continue to undertake further specific physician communications to improve patient outcomes or limit adverse events related to device behavior. Guidant Corporation pioneers lifesaving technology, giving an opportunity for a better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 12,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. . For more information, visit www.guidant.com. |
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