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St. Jude Medical's Riata Leads May Have Problems with Insulation

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A recent article in The Washington Post once again has called attention to the fact that Riata and Riata ST leads may cause problems for patients and for St. Jude Medical Inc. (SJM) of St. Paul, Minnesota.[1][1] If insulation around the lead wires in implanted heart devices, such as defibrillators and pacemakers, erodes, then the devices could malfunction.[2][2] An article in The New York Times pointed out that faulty leads may have been “linked to as many as 20 deaths.”[3][3]

The Food and Drug Administration (FDA), Center for Devices and Radiological Health director Dr. Jeffrey Shuren is advising patients with implanted heart devices, such as defibrillators, to undergo X-ray or other scan-type tests to ensure the integrity of the insulation of the Riata lead wires.[4][4]

According to the AP article, St. Jude Medical stopped selling Riata leads in late 2010 due to concerns about the integrity of the wires’ insulation and recalled the devices in 2011.[5][5] An estimated 79,000 Riata leads are implanted in patients throughout the U.S.[6][6]

St. Jude Medical has been ordered by the FDA to perform a three-year study on the risk of insulation failure in their leads. Riata leads are coated with silicone, according to the Post article. In addition, St. Jude Medical has been ordered to collect data on a variety of leads they market, including Riata, Riata ST, QuickSite, QuickFlex, Optim and Durata leads. Durata lead wires are insulated with polyurethane and SJM has not disclosed any problems patients may have had with them.[7][7]



[1][1] “FDA Says Patients Whose Heart Devices Include Certain St. Jude Medical Wires Should Have Scans”, Associated Press, August 16, 2012, The Washington Post, Washington, D.C.; http://www.washingtonpost.com/business/fda-says-patients-whose-heart-devices-include-certain-st-jude-medical-wires-should-have-scans/2012/08/16/fbbc4b72-e7e1-11e1-9739-eef99c5fb285_print.html

[2][2] Op. Cit.

[3][3] “FDA Asks St. Jude For More Studies on Flawed Heart Devices”, Thomas, Katie, August 16, 2012, The New York Times, New York, NY. http://www.nytimes.com/2012/08/17/business/fda-asks-st-jude-for-more-studies-on-flawed-heart-device.html?_r=2&ref=health

[4][4] FDA Says Patients..”, Associated Press, August 16, The Washington Post, Washington, D.C.

[5][5] Op. Cit.

6 Ibid.

7 Ibid.