St. Jude Medical Updates Eon Mini Recall—More People Injured
Eric ChaffinFebruary 19, 2013 12:09 PM
St. Jude Medical issued a “Dear Doctor” letter on July 26, 2012, reporting that over 200 people had complained of problems related to the Eon Mini implantable pulse generator (IPG). This letter served as an update to an earlier letter dated May 24, 2011, in which St. Jude announced an Eon Mini recall of several models found to be potentially defective.
Injuries related to the Eon Mini may include 1st and 2nd degree burns, reduced pain relief, and a return of difficult symptoms. Patients experiencing difficulties with the device often have to have it extracted and replaced, which can present additional health risks like pain, infection, scarring, and complications from anesthesia.
What is the Eon Mini IPG?
For patients who suffer from conditions like chronic back pain, dystonia, Parkinson’s disease, and other health problems in which standard treatments may not be affective, an IPG like the Eon Mini can provide welcome pain and symptom relief. Part of a treatment modality known as “neuromodulation,” the device generates electrical impulses that travel through “leads” to the spinal cord or brain, where they can either block pain messages or help control muscle spasms and tremors.
Similar to a pacemaker, the Eon Mini is placed under the skin and then connected to the area of the body that needs the electro-stimulation. Unlike older models that required replacement once the batteries ran out, the Eon Mini is rechargeable, and can be recharged at home. According to St. Jude Medical’s website, “The Eon IPG is FDA-approved to last at least 10 years at high stimulation settings, which means patients may need fewer replacement surgeries [.]”
According to an Eon Mini lawsuit filed on October 24, 2011, at least one woman had to have the Eon replaced after only six months, when it stopped working.
Eon Mini Recall in 2011
On May 24, 2011, St. Jude Medical implemented an Eon Mini IPG recall of certain models that carried a risk of being defective. According to a Dear Doctor letter sent out on that date, the company had received 78 reports of problems with the device, including a lost ability to communicate or recharge the battery. A company analysis revealed the problem was caused by weld failures within the internal battery. Doctors were advised to return unused devices and closely monitor patients who had been implanted with the potentially defective models.
The July 2012 Dear Doctor letter updated physicians with the latest information on the Eon Mini, including that the number of adverse event reports had risen to 214. Since the company made over 34,000 of the devices, there may yet be many more patients who are affected by potential malfunctions.
In this latest letter, St. Jude noted that they originally thought the weld failures were caused by moisture, but later determined that the problem was with an equipment supplier. They stated they were taking corrective action, and urged doctors to return unimplanted devices for free replacements.
Patients Seeking the Advice of an Eon Mini Lawyer
On October 24, 2011, an Eon Mini patient filed a new lawsuit in the State Court of Fulton County, Georgia. Represented by her Eon Mini lawyer, she stated that she was implanted with the device in December 2009, and that it stopped working in June 2010. She had to go through laporoscopic surgery to have it removed and replaced, and she’s seeking damages in court.
Other patients who have been injured by this device may benefit from consulting with a legal professional.