Riata leads from St. Jude Medical recalledIn an unusual move, the Food & Drug Administration in the United States issued a media release relating to certain defibrillator (ICD) products manufactured by St. Jude Medical. You can read the entire release about Riata leads on the FDA website. The announcement relates to leads with the brand name Riata and Riata ST. These are insulated wires, also known as leads, that are plugged into an implanted defibrillator (ICD) at one end and are fixated on the inside of the heart. When the ICD delivers defibrillation therapy (a shock) to restore normal rhythm to a fibrillating heart, the electrical energy travels through these leads. The leads are made by St. Jude Medical but can be used with an ICD device made by any company. People with these leads are urged to get X-ray or other images of the lead “to help guide treatment.”

In November 2011, St. Jude Medical recalled these leads because of reports of “premature erosion of the insulation around the electrical conductor wires.” This is also known as insulation failure, that is, the leads can wear through the insulation and this, in turn, can result in electrical shorts. The idea behind the X-ray or other imaging is to allow a physician to assess whether the lead exhibits any signs of such insulation failure. While Riata and Riata ST have been recalled, not all of these leads fail. However, these leads are susceptible to insulation failure and it is impossible to know from just the model number or other information which ones might fail.

St. Jude Medical reports that about 79,000 Riata or Riata ST leads are implanted in U.S. patients. St. Jude Medical stopped making the leads in 2010 and recalled them in 2011. If you have a Riata or Riata ST lead, you should contact your pacemaker doctor and ask about an X-ray or image that can help you assess the state of your particular lead. Most Riata leads do not fail.

If you are unsure what lead you have, here are some questions to ask:

  • Riata and Riata ST leads work only with defibrillators. If you have a pacemaker (no shocks), you do not have a Riata lead.
  • If you got a lead after 2011, you do not have a Riata or Riata ST lead because they were no longer sold. It’s unlikely you have a Riata or Riata ST lead if you got it after 2010, because they were no longer manufactured.
  • If you have an ICD from St. Jude Medical you may or may not have a Riata–Riata works with any brand defibrillator and it is not unusual for a physician to use leads from one manufacturer with an ICD device from another.
  • If you have a device ID card or other paperwork from your ICD implant, it may specify which leads you have, but not all people have such paperwork and not all paperwork names the type of leads.

 

If you do not know if you have a Riata or Riata ST lead, contact your physician and make sure you do not have a lead under recall. It is possible that you can have a recalled lead and not know it. In most cases, you should have heard from your physician, clinic, or St. Jude Medical already if you had a recalled lead–but sometimes that does not happen. It pays to ask.

If you have a Riata or Riata ST lead that is at risk of failure, this can be a serious concern. Insulation failure can allow some of the conductors of the wire to externalize or move outside of the insulation. This can cause the lead to malfunction. It can short out and cause an arrhythmia. It can also cause the lead to fail so that if you have a dangerous arrhythmia, the lead will not allow shock therapy to be delivered. These are potentially life-threatening situations.

Many failures in Riata and Riata ST leads have shown up in X-rays or other images, which are relatively easy, fast, and safe methods of getting valuable information. If you have a Riata or Riata ST lead and it is determined to be at risk of failure or in the process of failing, your doctor will discuss options with you. In some cases (but not always) he or she may advise you to have the lead removed and replaced with another brand of lead. However, the FDA does not recommend that Riata and Riata ST leads be routinely removed. Lead removal (also called lead extraction) is a surgical procedure and all surgical procedures carry with them some degree of risk. In other words, your doctor needs to evaluate with you your individual potential risks and benefits.

 

 

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