Patients who still have recalled St. Jude Defibrillators leads in their chests have many reasons to be vigilant. Premature insulation failure in the recalled device has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that leads to 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 perfect breeding ground for fungi and bacteria that can attack a patient’s heart.
Patients suffering from endocarditis may experience: high fever, new or different heart murmur, fatigue, muscle pain, chest pain, shortness of breath, coughing, night sweats, headache, blood in the urine, and unexpected weight loss. In addition, small spots from broken vessels under the nails, on the whites of the eyes, on the chest, in the roof of the mouth, and inside the cheeks, may also be experienced.
Treatment for Endocarditis
Treatment for endocarditis usually involves a course of antibiotics, such as gentamycin and penicillin, or if a patient’s heart valves are more severely damaged, surgery.
In earlier studies, endocarditis has been associated with intravenous drug abuse, dental infections, and surgical procedures. Patients who have had heart surgery, including a pacemaker implant, have an increased risk for this condition. In most of the occurrences, the infectious agent is streptococcal or staphylococcal bacteria or fungi, but usually, infections may be traced to one source.
Something different is identified in studies of endocarditis with premature insulation failure in recalled St. Jude Medical Riata defibrillator leads. Polymicrobial endocarditis has been found to develop from several infectious agents.
For some reason, there is more variety in the flora (in scientific literature referred to as “vegetations”) involved in these cases. The findings imply that, in the patient’s body, somewhere there is a fertile place for fungi and bacteria to flourish. The question has opened the possibility that the faulty insulation and resulting externalization (exposure) of St. Jude Medical Riata defibrillator leads may be the host.
The study that continues this theory notes, “The externalization of Riata leads 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.”
Product liability attorneys at Parker Waichman LLP are actively reviewing potential lawsuits regarding defective medical devices, including St. Jude defibrillators. Associates at the firm are available to answer any questions for individuals seeking information about filing a lawsuit.
In 2011, several studies suggested Riata lead wires revealed failures, and of those lead wires, it was only a matter of time and the impact could be fatal. A commonly reported malfunction associated with the Riata lead is its ability to break free of the silicone housing located at the connective ends of the leads. This defect has been corrected with a better connective end covering the leads.
Electrical Malfunctions and 22 Deaths
A study completed earlier that year was presented at the American College of Cardiology meeting in Chicago and was published online in the journal Heart Rhythm. The study found that electrical malfunctions of the defective St. Jude Riata leads may have been responsible for as many as 22 deaths. This study initially started a war of words between St Jude, Riata manufacturers and the authors of the study, as well as the journal that published the study.
Implanted cardiac defibrillator leads are responsible for synchronizing the rhythm of the heart and to provide necessary shocks to keep a heart’s rhythm regulated. Leads of all types have been associated with an erratic safety record and the failures of the Riata leads only represent a percentage of problems with the devices.
When these devices begin to fail, the connective ends break free of their protective housing. Though some leads continue working despite this defect, a study found that one-third of all leads that broke out of the silicone housing had failed and put patients at serious risk of injury or death.
St. Jude recalled the Riata defibrillator leads in 2010, after it was discovered that the wires could potentially penetrate their insulation, compromising the device’s integrity. This could cause the defibrillators to inappropriately shock some patients, and at other times fail to deliver life-saving therapy when needed.
Legal Information for St. Jude Defibrillator Recipients
If you or someone you know has sustained injury associated with a defective St. Jude defibrillator, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).