St. Jude Medical is committed to presenting information with accuracy and integrity. This website provides a compilation of important communications and updated information regarding Riata™ and Riata ST Silicone Defibrillation Leads.
To help physicians manage patient care, we are working to generate additional data and provide available information on these leads in a timely manner.
NEW Response to Heart Rhythm Journal Manuscript
On March 26, 2012, the Heart Rhythm Journal published a manuscript on their website titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.” This article is based on a search of the Food and Drug Administration’s MAUDE database of reported complaints and failures of our older generation Riata silicone leads. Given the known lack of information and reliability of the MAUDE database, it is not surprising that the manuscript published this week is not entirely accurate. Below you can view a response to this manuscript by Dr. Mark Carlson, chief medical officer for the St. Jude Medical Cardiac Rhythm Management Division.
Read Full Response
(added 28/March/2012)
NEW
St. Jude Medical Seeks Retraction of Heart Rhythm Journal Manuscript by Dr. Robert Hauser [Web Link]
ST. PAUL, Minn.--(BUSINESS WIRE)--Apr. 6, 2012
(added 6/April/2012)
NEW Food and Drug Administration MAUDE Database Reports: 377 Quattro Model 6947 deaths
Below please find a link to the actual reports taken directly from the Food and Drug Administration’s MAUDE database showing 377 deaths associated with the Medtronic Quattro Secure lead, rather than the 62 that was stated by Dr. Robert Hauser in a manuscript published online last week by the Heart Rhythm Journal. On Friday, April 6, 2012, St. Jude Medical called on Dr. Hauser to withdraw and retract the article based on this and other inaccuracies. On Monday, Medtronic indicated that it had researched the MAUDE database and provided an indication of support for Dr. Hauser's original analysis in its comments. Dr. Hauser's review of the number of deaths in the MAUDE database was wrong by an order of magnitude greater than six. All 377 reports on the Medtronic Quattro Secure lead are available below. We have called upon Dr. Hauser to state specifically whether or not he stands behind the factual accuracy of the number 62 used in comparing St. Jude Medical’s product to the Medtronic device. We also invite Medtronic to review the MAUDE database reports contained in this link. The Heart Rhythm Journal has requested this information, and again we respectfully ask that a manuscript that is inaccurate be immediately retracted and removed from online publication.
Read Maude Entries [PDF]
(Added 10/April/2012)
Riata Lead Evaluation Study
We recognize that the phenomenon of externalized conductors presents a complex patient management scenario for physicians as they can view an abnormality, but most leads with externalized conductors continue to function properly.
To help better understand this issue and guide any future recommendations regarding patient management, we have initiated the Riata Lead Evaluation Study, which will include a minimum of 500 patients, with Riata or Riata ST silicone-only insulation leads of varying implant duration. In patients with externalized conductors, electrical performance of the leads will be assessed every three months for two years.
Response to New England Journal of Medicine Perspective Editorial
On Feb. 14, 2012, the New England Journal of Medicine published a Perspective editorial on their website titled, “Here we go again – Another failure of postmarketing device surveillance.” The editorial highlights the need for additional post-market device data across the industry and outlines how this issue is illustrated by the recall of the St. Jude Medical Riata and Riata ST silicone-only defibrillation leads. We believe that there are inaccuracies and omissions in the editorial that are important to recognize in order to more fully understand this issue. Below you can view a full response to this editorial by Dr. Mark Carlson, chief medical officer for the St. Jude Medical Cardiac Rhythm Management Division, and a Letter to the Editor, written by Dr. Carlson and published by the New England Journal of Medicine.
Riata Lead Summit – SJM Perspective
View January 20, 2012 presentation from Dr. Mark Carlson, Chief Medical Officer for the St. Jude Medical Cardiac Rhythm Management Division, summarizing the Riata topic for participants of a physician meeting in Minneapolis.
Learn More
(added 20/January/2012)
(added 9/March/2012)
Patient Communication
St. Jude Medical is committed to keeping you and your doctor informed of all important product information.
Letter to Patients from St. Jude Medical [PDF]
Medical Device Advisory – Riata® and Riata® ST Silicone Endocardial Defibrillation Lead Performance
(added 1/February/2012)
Physician Communication
Important Product Information Update: Riata – November 2011 [PDF]
On November 28, 2011, St. Jude Medical provided a Medical Device Advisory and Important Product Information Update to physicians regarding the Riata Defibrillation Lead and the Riata ST Defibrillation Lead.
Important Information About Riata and Riata ST Silicone Endocardial Leads – December 2010 [PDF]
On December 15, 2010, St. Jude Medical provided Important Product Information regarding the Riata Defibrillation Lead and Riata ST Defibrillation Lead.
NEW Patient Management Guidelines
Because patient care is a top priority for St. Jude Medical, we have worked with an independent Medical Advisory Board to develop patient management guidelines regarding Riata silicone-only leads, which have been previously communicated and are aligned with the recommendations of other regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the industry physician organization the Heart Rhythm Society (HRS). In several instances, these guidelines differ from the recommendations of other regulatory bodies. Below are links to the patient management guidelines or recommendations from different regulatory authorities.
(added 10/April/2012)