Riata leads have an increased risk of premature insulation failure that can impact the lead’s ability to function properly, according to the FDA.
While most implantable cardioverter defibrillator (ICD) leads are expected to last at least 10 years, there is an increased frequency of Riata insulation failures within 4 years, according to the FDA. Insulation failure may cause some of the electrical conductors inside Riata leads to move within (migrate), or move entirely outside (externalize), the outer lead insulation.
If lead insulation fails, your lead may 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.
Riata Lead Recall
Riata’s manufacturer, St. Jude Medical Inc., recalled these leads on Nov. 28, 2011, due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure. St. Jude Medical stopped selling these leads in late 2010 but more than 227,000 Riata leads had been distributed worldwide. According to St. Jude Medical, as of 2011, approximately 79,000 Riata leads remained implanted in patients in the United States.
If you are one of the thousands of people with a recalled Riata defibrillator lead, you will need to be closely monitored by your doctor. If you have not had a recent evaluation and device interrogation, you should undergo those exams to assess for any electrical abnormalities.
St. Jude Medical recommends reprogramming the device to increase the chance for detection of a lead abnormality and turning on the patient alert and remote monitoring alerts.
If you suspect that an ICD lead has premature insulation failure, externalized or migrated conductors, electrical malfunction, or other abnormal function, you can contact our law firm. Fred will help you get compensation from St. Jude Medical and to report any concerns to the FDA.