St. Jude Riata Defibrillator lead Defects

11.12.07: Reports are circulating that St. Jude Riata defibrillators contain lead wires that can puncture holes in the heart wall of cardiac patients.

Backgroud:

St. Jude Riata defibrillators contain wires that connect the defibrillators to a patient's heart, and when working properly, they give patients an electric shock if the device senses an irregular heart rhythm. However, there are now reports that instead of staying attached to the heart, the defibrillator leads can actually poke holes in the patients' heart. If these leads become detached, a patient could die from an underlying medical condition, or if the heart wall is punctured the heart could bleed into the sac surrounding the heart, causing a deadly condition called "cardiac tamponade."

St. Jude and the FDA have received reports of perforations in four cases, and in one case, the tip of the lead was within millimeters of poking out of the surface of the patients skin.

St. Jude Medical and the FDA have not recalled St. Jude’s Riata defibrillator lead, however a recent article published in the December 2007 issue of PACE (the journal of Pacing and Clinical Electrophysiology) reported that several patients with the Riata lead have had their heart punctured by the device – a very serious health concern. Several cases of injury have been reported recently due to the Riata lead – two in the Czech Republic and two in the United States.

St. Jude Medical reported that of the 121,000 Riata leads it has examined upon being returned are due to a reported incident, .086 percent of those had a perforation incident – which equates to just over 10,000 incidents. Other St. Jude Medical studies that have followed estimate approximately 5,800 patients with the Riata lead show that perforation rates range from .6 percent to 5.2 percent.

What are defibrillator leads?

Defibrillators are small devices that are implanted into a patient’s chest that monitor their heart rhythm and provide an electrical shock when the rhythm is abnormal. The defibrillator lead, a small wire, attaches the device to the heart. Any problems that are encountered with leads are very serious as removing or replacing the leads requires risky surgery – something that most patients understandably try to avoid. A lead that punctures the heart’s wall can cause a condition called cardiac tamponade – which means that the heart may bleed into the pericardium sac that surrounds it, which increases pressure and prevents the heart from beating regularly.

What can I do?

If you have experienced any adverse effects from a St. Jude Defibrillator, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact attorney Ron Goldser directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.