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St. Jude ICD Defibrillator Recall Lawsuit


Attorneys are investigating possible ICD and CRT-D defibrillator lawsuits resulting from the devices possibly short-circuiting and causing harm to patients. St. Jude Medical Inc., issued a recall of some of its Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) implanted in about 400,000 people. The recall was prompted by the reports of two patient deaths.


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St. Jude Heart Device Lawsuit Investigation

As a follow up to the St. Jude ICD and CRT-D defibrillator recall and the FDA safety communication, the FDA sent St. Jude Medical, Inc. a warning letter on April 12, 2017. The letter states that St. Jude officials had systematically underestimated the true risk to patients by basing evaluations of battery failures only on "confirmed" cases of failure--rather than including cases in which the battery had shorted.

Given the severity of injuries reported, allegedly due to St. Jude ICD or CRT-D defibrillator failure, attorneys are now investigating victims' claims for possible defibrillator injury lawsuits.

FDA Safety Communication for St. Jude Heart Devices

The US Food and Drug Administration (FDA) issued a Safety Communication regarding the devices and St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. They are warning patients with these devices to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert.

The implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. Deposits of lithium, known as “lithium clusters,” can form within the battery and create abnormal electrical connections leading to rapid battery failure.

St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.

St. Jude ICD and CRT-D Device Recall

The following St. Jude ICD and CRT-D device models are involved in the October, 2016 FDA Class 1 Recall The affected models have been manufactured before May, 2015.
  • Fortify VR
  • Fortify ST VR
  • Fortify Assura VR
  • Fortify Assura ST VR
  • Fortify DR
  • Fortify ST DR
  • Fortify Assura DR
  • Fortify Assura ST DR
  • Quadra Assura
  • Quadra Assura MP
  • Unify
  • Unify Asssura
  • Unify Quadra

To date, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters.

Two deaths (1 in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion.

10 patients (9 in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.

37 patients (30 in the U.S.), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.

ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

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Faulty St. Jude Riata Defibrillator Leads Eyed for Link to Heart Infections
Faulty St. Jude Riata Defibrillator Leads Eyed for Link to Heart Infections
September 11, 2017

Washington, DC: Premature Insulation Failure in recalled St. Jude Medical Riata Defibrillator (ICD) Leads has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that causes inflammation of the heart lining, muscles and valves. The decayed insulation on the electrical leads that connect the pacemaker to a patient’s heart may be a fertile breeding ground for bacteria and fungi that can attack a patient’s heart.

Patients who still carry recalled St. Jude Defibrillators leads in their chests have many reasons to be wary. This is another one that needs to be watched. Left untreated, endocarditis is always fatal.

Patients suffering from the condition may experience:
  • High fever;
  • New or different heart murmur;
  • Fatigue;
  • Muscle pain;
  • Small spots from broken blood vessels under the nails, on the whites of the eyes, on the chest, in the roof of the mouth and inside the cheeks;
  • Chest pain, shortness of breath, coughing;
  • Night sweats;
  • Headache;
  • Blood in the urine; or
  • Unexpected weight loss.
Treatment commonly involves a course of antibiotics, such as penicillin and gentamycin, or surgery when a patient’s heart valves are more severely damaged.

In previous studies, endocarditis has been linked to intravenous drug abuse, dental infections and surgical procedures. Having had heart surgery, including a pacemaker implant has long been recognized as increasing a patient’s risk for the condition. The infectious agent in most of the occurrences is streptococcal or staphylococcal bacteria or fungi, but for the most part, infections may be traced to a single source.

The studies of endocarditis in patients with premature insulation failure in recalled St. Jude Medical Riata defibrillator (ICD) leads shows something different. Polymicrobial endocarditis arises from several infectious agents.

There is, for some reason, more variety in the flora (referred to in the scientific literature as “vegetations”) involved in these cases. The findings suggest that, somewhere in the patient’s body, there is a fertile place for bacteria and fungi to flourish. The inquiry has moved to the possibility that the faulty insulation and resulting exposure (or externalization) of St. Jude Medical Riata defibrillator leads may be the host.

The study  that advances this theory notes that, “The externalization of Riata lead may cause the malfunction but it could also promote bacterial colonies and vegetations. In conclusion, looking for early signs of infection is mandatory during Riata leads follow-up checks.”

Insulation Failure, Battery Failure and Cyber Hacking - A Triple Threat for Pacemaker Patients
Insulation Failure, Battery Failure and Cyber Hacking - A Triple Threat for Pacemaker Patients
August 24, 2017

Washington, DC: Premature insulation failure in recalled St. Jude Medical Riata defibrillator (ICD) leads may be only the tip of the iceberg for heart patients with ICDs, more commonly known as “pacemakers.”

In 2011 St. Jude Medical Inc. recalled the electrical leads used to connect the Riata pacemaker to patients’ hearts because of flaws in the protective insulation. Failure of the insulation on an electrical lead can cause a pacemaker to deliver inappropriate stimulation to the user’s heart. For cardiac patients with abnormal heart rhythms, the disruption can be fatal. In addition, the exposure of the electrical lead has been linked to polymicrobial endocarditis, a serious bacterial infection of the heart. St Jude stopped marketing the defective leads in 2010, but thousands remain implanted in chests of patients in the United States.

The problems with St. Jude ICDs aren’t limited to the electrical leads. In 2016, the FDA issued a safety warning about the lithium batteries used to power them.

The ICDs are designed to alert patients to seek medical intervention to replace the battery approximately three months before it fails. St Jude has reported, however, that deposits of lithium, known as “lithium clusters,” can form within the battery, creating abnormal electrical connections that cause the battery to fail quickly. In some cases, full battery drainage has occurred in as a little as a day, leaving the patient with little or no time to get medical attention.

Finally, cybersecurity researchers at the University of Leuven in Belgium and the University of Birmingham in England have reported that they were able to successfully hack into ten different ICDs using relatively inexpensive, easily obtainable electronic components and a radio antenna.

In January 2017, the FDA warned that vulnerabilities in St. Jude Medical's ICDs might allow a hacker to deplete the battery or administer incorrect pacing or shocks. The hacker’s access point is a remote device programmer, intended to allow doctors and other medical professionals to adjust the settings on the pacemaker from up to five meters away.

St. Jude thereafter developed a patch to fix the devices’ susceptibility, but a later FDA warning letter suggests that the patch, itself, has not been adequately tested.

Patients who have an ICD manufactured by St. Jude Medical, Inc. would do well to seek medical advice about their risks and options.

Implantable Defibrillators with Faulty Batteries Lead to Class Action
Implantable Defibrillators with Faulty Batteries Lead to Class Action
August 12, 2017
Toronto, Ontario Thousands of Canadians and American cardiac arrhythmia patients with implantable defibrillators powered by faulty ion batteries and manufactured by St. Jude’s Medical Inc. and St. Jude’s Medical Canada are or will soon be eligible to join class actions suits in Canada and the US. READ MORE


Posted by

My dad just had a St. Jude ICD model CD1357-40Q replaced after 13 months, malfunction of capacitor/battery. have you had any suits on this. They replaced with same model, suppose to be good for about 10 years.

Posted by

My husband had to defibrillator pacemaker put in so he was having issues with finished with blue flashes that would bring them down to ground we went back to Saint Jude and they said everything's fine with in a couple months if he passed away I found out to another lawyer in New York that they had a lawsuit against Saint Jude and they said they couldn't do anything because the product was not me called I found out the product was recalled just do you couple days ago need to find out if the pacemaker defibrillator reader we're default All his medical records even the card for the pacemaker


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