St. Judes Riata Line of Defibrillator Leads May Puncture Holes in Patient’s Heart

Not long after Medtronic pulled a flawed Sprint Fidelis leads off the market because of an apparent tendency to break, there are concerns that similar leads sold by St. Jude Medical may in rare cases puncture holes in patients’ hearts. Both cases concern wires, known as leads, that monitor the heart and transmit an electrical jolt to restore normal heartbeats.

A defibrillator lead is a thin wire that attaches an implantable defibrillator to the heart. When a defibrillator lead wire detaches, it can poke a hole through the heart wall. If this happens the heart can bleed into the pericardial sac around it, leading to a lethal condition called cardiac tamponade.

While such malfunctions can happen with any defibrillator lead, evidence is emerging that such detachment and perforation is occurring more frequently than expected with the St. Jude Riata Defibrillator Leads. Our office represented a woman whose pericardium and right atrium was perforated by the atrial lead while having a defibrillator implanted by prominent interventional cardiologists. Immediately after the procedure, our client experienced shortness of breath and chest pain. The doctors failed to diagnose that in inserting the defibrillator.

Instead, our client was incorrectly diagnosed with an inflammatory process. As such, our client was unnecessarily treated with steroids over a period of time, and she underwent numerous thorancentesis procedures due to multiple, recurrent pleural effusions. Eventually our client went to a hospital in New York City where a correct diagnosis was made.

Unfortunately, as a result of the unnecessary steroid treatment, our client developed avascular necrosis and had to have surgery for a hip replacement. The medical journal PACE published several case reports of St. Judes Riata line of defibrillator leads poking holes in the heart, a problem that can lead to potentially fatal bleeding. But reports earlier this year in the journal Heart Rhythm found higher rates of perforation.

One series from Massachusetts General Hospital found a 3.8% rate of perforations in 130 patients given certain models of Riata leads. The company says a patient registry has found a perforation rate of 0.33% in one of its patient registries comparable to or lower than the rates for other leads.

However, at least one heart expert has disputed St. Judes contention, telling the Wall Street Journal that the company’s data could be misleading since physicians, such as the ones in the case we handled discusses hereinabove, don’t always report instances of heart perforations from defibrillator lead wires. Medical device manufacturers don’t always have accurate figures regarding failures.

For example, Medtronic Inc. recalled its Sprint Fidelis Defibrillator Lead over a fracturing problem after initially insisting that the Minneapolis Heart Institute’ information to Medtronic that the Sprint Fidelis Lead had a higher-than-normal fracture rate was wrong and that Medtronic’s own data indicated no such problems. It was only following a new analysis of its data, Medtronic ultimately pulled the Sprint Fidelis Lead from the market in October.

The personal injury lawyers at Levine & Slavit have decades of experience handling personal injury claims including those involving dangerous and defective products . For 50 years spanning three generations, we have obtained results for satisfied clients. We have offices in Manhattan and Long Island, handling cases in New York City, the Bronx, Brooklyn, Queens and surrounding areas.

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