On Nov. 28, 2011, the medical device manufacturer St. Jude Medical, Inc. issued a recall of its Riata and Riata ST Silicone Endocardial defibrillator leads. “Leads” are the wires that connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms for life-threatening heart rhythms (arrhythmias) and to deliver electrical shocks to the heart when needed.
St. Jude issued the recall due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure. St. Jude stopped selling these leads in late 2010 but more than 227,000 leads had been distributed worldwide. According to St. Jude, as of 2011, approximately 79,000 Riata leads remain implanted in patients in the United States. 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, which can result in malfunctions. ICD lead malfunctions may cause abnormal sensing or pacing, as well as delivery of inappropriate shocks or no shocks.
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.
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If you or a loved one has been harmed a defective heart device, we invite you to consider Terrell ● Hogan. For a free consultation, call (904) 722-2228 or 1-888-244-5557 (toll free).