Some patients who received St. Jude Eon Mini implant surgery have complained about reduced pain relief, a return of symptoms, suffered from burns, or needed the device removed after surgery. The FDA issued recalls after learning of potential issues with the Eon Mini battery and patients experiencing burns on their skin.
Patients may need another surgery to correct the problem, also known as explant surgery. The FDA says if you need an explant surgery, this could present a risk to your health. You could experience pain, scarring, and infections, as well as complications from anesthesia.
What is an Eon Mini?
The Eon Mini implantable pulse generator (IPG) was approved by the FDA in April 2008. The device is used to help people suffering from chronic leg and back pain. St. Jude Medical said the device had the longest battery life of any other spinal cord stimulation (SCS) device. SCS is a form of neuromodulation which can help patients with several conditions including: primary dystonia; essential tremor; Parkinson’s disease; and chronic back and leg pain associated with failed back surgery syndrome (FBSS).
FDA Issues Class 2 Recall of the Eon Mini
The first Class 2 recall of the Eon Mini was issued in May 2010 by the FDA, two years after it came on the markets. They found that the device was not charging properly.
St. Jude Medical issued a “Dear Physician” letter asking doctors to return any device manufactured before September 2010. St. Jude then issued an Eon Mini recall in May 2011. Doctors were told to follow-up with patients who had received an Eon Mini during implant surgery.
St. Jude issued another “Dear Physician” letter in December 2011 citing warmth and heating when patients charged the Eon Mini.
The FDA issued another Class 2 recall in July 2012 of the Eon Mini Neurostimulation (IPG) system citing loss of battery life, which caused patient pain to return.
In August 2012, the FDA issued a Class 2 recall for the Eon Mini citing 110 complaints from patients who experienced warming or heating at the implant site.
Then, in August 2013, the FDA issued yet another Class 2 recall. This was due to over 200 reports received by St. Jude Medical citing an inner battery issue with the Eon Mini.
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