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Recommendations on the approach to patients with Riata and Riata ST leads (St. Jude Medical)

Case no. 4270/11 and 5563/11

Riata and Riata ST implantable cardioverter defibrillator (ICD) leads (St. Jude Medical, Sylmar,
CA) show an increased incidence of insulation defects, particularly “inside-out” lead
fracture where inner, separately insulated cables penetrate through the surrounding silicone
of the lead body.

The German Cardiac Society (DGK, nucleus of the Task Force rhythmology) now published recommendations regarding patients with Riata and Riata ST silicone insulated defibrillation leads. Corresponding author is the spokesman of the working group, Associate Professor Dr. Carsten W. Israel from Bielefeld. The recommendations can be found in the magazine „Herzschrittmacher + Elektrophysiologie“: Herzschr Elektrophys 2012 23:107–115 DOI 10.1007/s00399-012-0186-x.

They are available at the following internet link:
Recommendations on the approach to patients with Riata and Riata ST leads (St. Jude Medical)

Further information in German (as of 2014):


In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Facsimile: +49 (228) 207-5300
e-mail: medizinprodukte@bfarm.de
Phone: +49 (228) 207-5384 (active medical devices and medical technology)