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St Jude Defibrillators

St. Jude Defibrillator Side Effects Lawsuits | Side Effects: Cardiac Tamponade Perforates Heart Tissue, Heart Damage, Irregular Beating | Defective Lead Wires, Perforation Problems

St. Jude Defibrillator Side Effects May Be Linked To Cardiac Tamponade Lawsuit Lawyers

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 in which 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 may bleed into the pericardial sac surrounding the heart. This causes a lethal condition called cardiac tamponade in which pressure builds around the heart, preventing the heart 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.

St. Jude Defibrillator Side Effects

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 Battery Defect Linked to Two Deaths

On October 11, 2016, St. Jude Medical warned of a battery defect affecting its Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device. According to a safety alert posted on the U.S. Food and Drug Administration (FDA) website, the batteries on these heart devices may fail sooner than expected. St. Jude is urging patients and caregivers to respond to the Elective Replacement Indicator (ERI) alert as soon as it goes off. Normally, the patient has three months to receive a new battery when the ERI alert is active. However, St. Jude has received reports of the battery failing as early as 24 hours after receiving the ERI alert. A recall and correction was initiated.

The heart devices are used to provide pacing for patients with slow heart rhythms, and administer an electrical shock in patients who have a dangerously fast heart rhythm. The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) are implanted in the upper chest, underneath the skin and connected to the heart through “leads” or insulated wires. According to the FDA safety alert, the following ICD and CRT-D models manufactured before May 2015 are affected:

  • Fortify VR
  • Fortify ST VR
  • Fortify Assura VR
  • Fortify Assura ST VR
  • Fortify DR
  • Fortify ST DR
  • Fortify Assura DR
  • Fortify Assura ST DR
  • Unify
  • Unify Quadra
  • Unify Assura
  • Quadra Assura
  • Quadra Assura MP

The defect stems from the devices' lithium-based batteries. The alert states that deposits of lithium, known as “lithium clusters,” may form within the batteries of ICDs and CRT-Ds. If this occurs, the defect may disrupt the normal electrical connections and cause rapid battery failure. In some cases, the battery fully drained a day or a few weeks after the patient received an ERI alert. This defect may be fatal; if the battery drains the device will be unable to provide a life-saving shock. “The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent,” the alert notes.

Nearly 400,000 Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices were sold worldwide. Premature battery failure prompted 841 of these devices to be returned for analysis. So far, the recall has been linked to two patient deaths when the battery was unable to deliver a life-saving shock. There have also been 10 reports of patients fainting and 37 reports of dizziness when the battery was unable to provide the necessary therapy. The alert notes that these figures may be an underestimation because issues are not always reported to the manufacturer.

St. Jude Defibrillators (Side Effects: Cardiac Tamponade Perforates Heart Tissue, Heart Damage, Irregular Beating | Defective Lead Wires, Perforation Problems)

In April 2009, St. Jude Medical Inc., the maker of implantable devices that regulate heart rhythms, identified that 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 FDA 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, 60 out of an approximate 36,000 devices have been found to be affected, the company wrote 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 irregular heart beat back into rhythm. St. Jude indicated that 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 patient's 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).

Parker | Waichman Logo Legal Help For Victims Affected By St. Jude Defibrillators
If you or someone you know 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 or call us at 1-800-YOURLAWYER (1-800-968-7529).


St Jude DefibrillatorsRSS Feed

St. Jude Medical Slow in Reacting and Removing Faulty Defibrillators

Apr 17, 2017
St. Jude Medical responded to a warning letter issued by the U.S. Food and Drug Administration (FDA) by recalling an allegedly faulty medical device. The warning issued April 12, 2017 states that during an inspection of the facility located in Sylmar, California on February 7, through February 17, 2017, investigators from the FDA determined that the facilities that manufacture the Fortify, Unity, Assura (including Quadra) defibrillators were not compliant with FDA standards. Defibrillator...

St. Jude Medical Recalls ICD and CRT-D Defibrillators

Jan 20, 2017
Implantable Cardioverter Defibrillators Subject of Recall Following Deaths St. Jude Medical Inc. recently announced a recall of about 400,000 implanted heart devices over risks of premature battery depletion. The defect has been associated with two deaths. The U.S. Food and Drug Administration (FDA) has deemed the recall a Class I, which is the agency's most serious type of recall and indicates that use of these devices may lead to serious injuries or death. St. Jude...

After Correcting Battery Depletion Issue, St. Jude Continued to Sell Old ICDs

Nov 2, 2016
St. Jude says it continued to ship old versions of its heart devices after the company implemented a design change that prevents premature battery failure. Ultimately, early battery depletion has prompted the devices, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to be recalled. Various models of Fortify, Unify and Assura were affected by the recall. ICDs and CRT-Ds are heart devices implanted under the skin in the upper chest....

FDA Places Highest-Risk Class I Label on St. Jude ICD CRT-D Recall

Oct 27, 2016
The U.S. Food and Drug Administration (FDA) has placed its most serious Class I label on a St. Jude Medical recall affecting hundreds of thousands of pacemakers prone to premature battery depletion. The devices in question are implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), which provide pacing in patients with slow heart rhythms and pacing or shocks in patients with fast heart rhythms. The recall affects certain models of the...

St. Jude Medical Recalls Battery for Heart Devices Following 2 Patient Deaths

Oct 13, 2016
St. Jude Medical is recalling batteries used in its Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) heart devices. The recall is being issued due to early battery failure, which has been linked two patient deaths. The devices are used to deliver an electrical shock to patients with a dangerously fast heart rhythm, or provide pacing for patients with a slow heart rhythm. Nearly 400,000 devices are implanted worldwide; 841 have been...

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