The United States Food and Drug Administration (FDA) has issued a press release and safety notices concerning Riata and Riata ST Silicone Endocardial Leads manufactured by St. Jude Medical Inc. Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. ICD can detect life threatening heart rhythms and deliver an electrical shock from the ICD through the lead to the heart.

In December 2010, St. Jude Medical reported that the outer insulation material, silicone rubber, had been observed to be vulnerable to abrasion and might lead to premature insulation failure that could impact the lead's ability to function properly. Lead insulation failure may cause the ICD lead to malfunction. ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death. St. Jude had phased-out all models of Riata and Riata ST silicone leads in December, 2010.

According to the FDA, the increase in frequency of reported Riata insulation failures began approximately four years after implantation. However, there is currently not enough information to determine how often and how soon the Riata insulation fails and the risk factors of insulation failure or externalization of the electrical conductors. The FDA issued a press release and safety notices to provide information and recommendations regarding safety concerns with the products.

Recommendations for healthcare professionals:

• The affected patients should be monitored closely and assessed for any electrical abnormalities.
• Physicians should image Riata and Riata ST leads implanted in patients to assess for externalization or other visible insulation abnormalities, if it is not contraindicated.
• Physicians should consider remote monitoring for patients to better detect electrical abnormalities.
• Jude Medical recommends reprogramming the device to increase the chance for detection of a lead abnormality. The patient alert and remote monitoring alerts should also be turned on.
• The FDA, St. Jude Medical and the Heart Rhythm Society do not recommend routine removal of any leads due to the risks of explantation surgery. Physicians should only consider replacing the lead if there is evidence of insulation failure in imaging and if there is abnormal electrical function.

Recommendations for patients:

• Patients should contact their cardiac physician to determine if they have the affected leads.
• Patients are advised to discuss with the physicians to find out the best management plan they should adopt.

The FDA is requiring St. Jude Medical to conduct three-year post-market surveillance studies to address concerns related to premature insulation failure and to address important questions related to follow-up of affected patients.

According to the local supplier, the affected models have been distributed in Hong Kong. For details, please refer to FDA website:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm314930.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315684.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315718.htm

Patients who have ICD with Riata and Riata ST leads, please contact their physician for necessary actions. For healthcare professionals, please contact your supplier for information.

Posted on 17 August 2012