Patients who were implanted with a St. Jude Medical Eon Mini and then experienced difficulties with the device may be eligible to file an Eon Mini lawsuit. A recent update to the previous Eon Mini Recall in May 2011 stated the company has received 214 reports of incidences where the device œlost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant.
St. Jude Medical has also received reports from people who experienced 1st or 2nd-degree burns on their skin due to battery overheating while recharging. At least one woman has already sought the expertise of an Eon Mini lawyer in an effort to recover damages in court.
What is the Eon Mini?
According to Georgetown University, some 16 million adults experience persistent or chronic back pain, which is a leading cause of lost workdays. Many of these individuals are unable to find relief with traditional over-the-counter pain relievers or other therapies, but have had great luck with a treatment called œneuromodulation.
Neuromodulation uses electrical signals to stimulate or block different nerve impulses in the body. Just like a pacemaker helps manage the rhythm of a heartbeat, new implantable pulse generators (IPGs) generate electric pulses that interrupt or mask the transmission of pain signals to the brain.
The Eon and Eon Mini are battery powered electronic devices that are implanted under the skin next to the spinal cord. Signals from the device are transmitted to the spinal cord through œleads that run from it to the epidural space in the spinal area. Similar devices may also be placed in the chest and connected to the brain to help reduce symptoms of dystonia and Parkinson’s disease.
The Initial Eon Mini Recall
On May 24, 2011, St Jude implemented an Eon Mini recall, withdrawing certain models of the Eon Mini and Brio IPGs from the market. They issued a letter to doctors explaining that they had received 78 reports of problems with the devices”namely, that they lost the ability to communicate or recharge. Patients wearing the defective devices could experience a loss of pain relief or a recurrence of symptoms, and would likely have to go through an explant surgery to have the defective devices removed and replaced.
The company stated they believed the problems stemmed from œweld failures within the internal battery, which caused them to leak and prevented the devices from holding a charge. Because the inner battery is fully contained within the hermetically sealed case, patients were not exposed to the leaking electrolyte material, but did suffer from device failure.
Eon Mini Lawyer Notes Increase in Adverse Event Reports
On July 26, 2012, St. Jude Medical issued an update to the previous Eon mini recall. They noted that the number of adverse event reports had increased to 214, and acknowledged that since the devices numbered over 34,000, more patients may yet be affected. They added that their initial product analysis had indicated moisture was the cause of weld cracking, but further investigation found the problem originated with an equipment supplier.
St. Jude further advised doctors to return any affected unimplanted devices for free replacements. For implanted devices, the company advised close monitoring should be done to watch for any malfunctions. They added that they had taken corrective actions to address the problems in new devices.
Eligibility for an Eon Mini Lawsuit
St. Jude states in its doctor letters that explant surgeries, like all surgeries, present certain health risks including pain, scarring, and infection, as well as complications from anesthesia.
Patients who have experienced skin burns, reduced pain relief, or increased symptoms because of an Eon Mini malfunction may benefit from a consultation with an Eon Mini Lawyer. St. Jude Medical states on its website, œThe Eon IPG is FDA-approved to last at least 10 years at high stimulation settings, which means patients may need fewer replacement surgeries, and it is designed to provide consistent pain therapy for virtually any pain profile.
Patients whose devices failed after six months, for example, or who suffered skin burns, may have claims against St. Jude Medical such as breach of warranty and failure to warn. Chaffin Luhana LLP has years of experience representing victims in personal injury lawsuits, and will work aggressively to help you obtain the compensation you deserve. Call today for a free and confidential case evaluation at 1-888-480-1123.