Home > Blog > A Heart Device With Known Problems Not Recalled Until 2011

A defibrillator is a medical device that delivers a shock to the heart when a patient suffers a life-threatening arrhythmia.  To patients with heart problems, this device can be a lifesaver, and it’s proper functioning is a matter of life and death.  But the Riata defibrillator, manufactured by St. Jude Medical, has been having problems with its leads since 2006.  Despite the fact that doctors were reporting abrasion issues to the company, a recall of the Riata defibrillator did not occur until 2011.

What is a defibrillator lead?

The lead connects the device to the heart in order to monitor the heart’s rhythms, so the device itself can detect irregular heart rhythms.

What was the problem with the Riata lead?

Defibrillator leads are covered in layers of insulation that protect the wires inside.  But with these particular leads, the insulation prematurely erodes away, leading to malfunction.  Doctors began reporting this problem to St. Jude Medical in 2006, but the company considered the problems to be isolated incidents.  However, internal documents show that the company was more aware of these problems than was initially thought, and there was even an audit performed concerning this problem in 2008.

Was the Riata lead recalled?

The Riata defibrillator was finally recalled in 2011, but almost 80,000 people in the United States still have one.  Unlike medication, a medical device can not be easily stopped or substituted.  Because St. Jude Medical did not choose to act more quickly on the information that was mounting, many people will now have to be closely monitored in order to make sure that they do not develop any of these problems.  A study done in July of 2012 revealed that this problem occurs in almost 19% of patients with the device.

What makes the Riata lead more likely to fail?

According to the FDA, most leads last at least 10 years, but problems with the Riata lead area appear after approximately 4 years.  They have not been able to determine what makes these leads more likely to fail.

What should patients with Riata leads do?

Contact your doctor.  If you have not had a recent check-up, your doctor might want to do so.  Monitoring might have to be done more closely and more often.

What are the symptoms of a malfunction?

Symptoms that something might be wrong with the lead include multiple shocks, lightheadedness, fainting, or palpitations.