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St. Jude Riata Defibrillator Lead Wires Perforation Problems

In November 2007, reports emerged that St. Jude Riata Defibrillator Lead wires had perforated the hearts of some patients.   That month, the medical journal “Pace” published a report detailing four instances where the St. Jude Riata Defibrillator Lead wire detached and perforated the heart wall.  In one instance, the defective St. Jude Riata Defibrillator Lead wire not only perforated the heart, but it nearly poked through a patient’s skin. 

When a defibrillator lead wire becomes detached from the heart, the device will fail to emit needed electrical shocks to the heart, leaving a patient at risk of death.   If the detached St. Jude Riata Defibrillator Lead perforates the heart tissue, the heart can bleed into the pericardial sac around it.  This causes a lethal condition called cardiac tamponade in which pressure builds around the heart, preventing it from beating effectively.  In an editorial accompanying the “Pace” article, Dr. Stephen Vlay, a cardiologist for Stony Brook University, wrote that the problems with the St. Jude Riata Defibrillator Leads could be due to an “inherent design flaw, at least in some models of the Riata lead.” 

Earlier in 2007, the medical journal “Heart Rhythm” reported that the St. Jude Riata Defibrillator Lead had a higher perforation rate than what had been stated by the manufacturer.  According to that article, doctors at Massachusetts General Hospital reported a perforation rate of 3.8% - or 5 out of 130 – for the St. Jude Riata Defibrillator Lead.  Doctors from New York Hospital Queens also reported to “Heart Rhythm” that of 59 St. Jude Riata Defibrillator Leads implanted there, five had perforated.   New York Hospital Queens has since stopped using the defective St. Jude Riata Defibrillator Lead.

St. Jude Defibrillators
St. Jude Medical Inc., the maker of implantable devices that regulate heart rhythms, said it has identified a memory chip problem in a small number of some of its older devices. While no deaths or serious injuries have been reported to the company as a result of the problem, St. Jude said in a government filing that the U.S. Food and Drug Administration may classify the problem as a recall.

The problem which stems from a memory chip that St. Jude used through 2002 that is susceptible to background radiation has not been seen in any of the devices the company currently sells. The St. Jude implantable cardioverter defibrillators (ICDs) that may be affected by the radiation problem are certain older generations of the company's Photon DR, Photon Micro VR/DR and Atlas VR/DR models.

So far, only 60 out of an approximate 36,000 devices have been found to be affected, the company said in the filing. Nearly 26,000 of the devices remain in patients.

St. Jude Medical Inc. has notified doctors and federal regulators of a software problem in some models of its implantable defibrillators that could cause the heart-shocking device to malfunction. About 39,000 patients are affected by this news.

ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an irregularer heart beat back into rhythm. St. Jude said it discovered the two "anomalies" during a routine product evaluation.

In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the patients heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. The devices on average last four to seven years before replacement. A second problem could cause a temporary increase in the device's pacing rate. In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.

The affected models include: Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF(V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350), Atlas DR (V-242), and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343).

If you or a loved one suffered injuries from a St Jude defibrillator, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.