St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Increased Risk of Premature Insulation Failure

The US FDA informs Cardiology, Radiology, Surgery and Family Care Physicians that St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads have increased risk of premature insulation failure and they might not work properly.

Background of Riata Implantable Cardioverter Defibrillator (ICD) Leads

Riata Implantable Cardioverter Defibrillator (ICD) Leads, by St. Jude Medical, Inc., are used to connect an Implantable Cardioverter Defibrillator to the heart for heart rhythm monitoring. When detecting life-threatening heart-rhythms the ICD delivers an electrical shock to the heart via the lead. FDA Alert on St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads

FDA’s reason for the communication is that safety concerns exist regarding the recalled Riata leads. The leads were recalled on Nov. 28, 2011 because of premature erosion. It is estimated that more than 227,000 Riata leads had been distributed all over the world and, as of 2011, approximately 79,000 Riata leads are still implanted in patients in the United States.

The specific leads have an increased risk of premature insulation that may cause leads’ malfunction, resulting in severe adverse events, including death.

Recommendation on St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads

“Physicians should continue to closely monitor patients who have a Riata or Riata ST lead and notify patients if they have a recalled lead.  Patients who have not had a recent evaluation and device interrogation should undergo those exams to assess for any electrical abnormalities.  Physicians should consider remote monitoring for patients with a recalled lead to better detect electrical abnormalities.

St. 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.”

Contacting the FDA to report cases on St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads

In case of detection of premature insulation failure, externalized or migrated conductors, electrical malfunction, or other abnormal function related to the use of St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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