St. Jude Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) has classified its voluntary medical device advisory letter to physicians from Nov. 28, 2011, regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I Recall, the most serious type of recall involving situations in which there is a reasonable probability that use of the recalled product will cause serious injury or death if it malfunctions.
The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).
An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010.
As communicated in the Physician Advisory Letter, if the electrical integrity of a defibrillation lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy).
St. Jude Medical acknowledges that the clinical implications of leads with electrically intact externalized conductors are not fully known at this time. Consequently, more data are required in order to assess if specific patient subgroups with electrically intact externalized conductors are at greater risk or should be managed differently. Patients who require frequent defibrillation or who are pacemaker dependent may be considered to be at greater risk.
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“At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads,” said Dr. Anne Curtis, professor and chair of Medicine at the University at Buffalo, former Heart Rhythm Society (HRS) president and a member of St. Jude Medical’s Medical Advisory Board (MAB). Also, over the next several weeks, there are two public meetings scheduled to discuss Riata and associated clinical recommendations: A Riata Leads Issue Webinar sponsored by the Heart Rhythm Society on Dec. 21, 2011 and a Riata ICD Lead Summit sponsored by the Minneapolis Heart Institute Foundation on Jan. 20, 2012.
Read more 2011 news and topics:
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- Lawsuit for Child Injured in a Traffic Accident Caused by Parent.