Reports of St. Jude’s Riata defibrillators leads causing heart punctures began to surface in November 2007, raising new concerns about the safety of such devices. In one reported case, the wire lead came just millimeters from puncturing through a patient’s skin. These events are extremely serious and may result in fatalities. As many as four deaths and 15 non-fatal incidents involving Riata leads and heart punctures have been reported to the government’s adverse event reporting program.

If you or someone you love has been injured because of a defective defibrillator lead, one of our attorneys will gladly explain your legal rights free of charge. Contact our office today.

PACE Cases
The journal of Pacing and Clinical Electrophysiology cited four cases of heart perforations in women implanted with St. Jude’s Riata defibrillator leads. The cases involved two patients from the Czech Republic, one from New York, and one from Nebraska. In each of the cases, the Riata lead is believed to have caused heart perforations.

Serious Consequences
Defibrillator leads such as St. Jude’s Riata model consist of a small wire implanted into the heart to deliver a shock when an abnormal rhythm is detected. The devices can be life-saving.

However, if the lead becomes detached from the heart, a couple of serious events could occur:

1) The lead could poke a hole in the heart, allowing blood to leak into the surrounding sac. When fluid builds up around the heart, it inhibits the heart’s ability to beat effectively. This condition is known as cardiac tamponade, and it is potentially fatal.

2) The lead could fail to pick up on abnormal heart rhythms—also a potentially deadly problem.

Hospitals, Doctors Stop Using Riata Leads
In an editorial accompanying the PACE report, cardiologist Dr. Stephen Vlay noted that some hospitals have stopped using Riata leads altogether. According to Dr. Vlay, “there may be an inherent design flaw” in certain Riata models.

Earlier this year, reports describing higher heart perforation rates with Riata leads were published in the journal Heart Rhythm. Following that publication, several letters were submitted to the journal citing additional instances of Riata leads causing heart perforations and two doctors said they stopped using the leads.

Defective Medical Devices
The report in PACE came just weeks after Medtronic recalled certain models of its popular Sprint Fidelis defibrillator leads over the potential for lead fracture and malfunction. At least five deaths have been associated with defective Sprint Fidelis leads.

Medical device makers may be held responsible for damages caused by defective products. If you have been injured by a defective medical device and would like to learn more about your legal rights, contact us today. We’ll be happy to answer your questions in a complimentary consultation.