St. Jude Eon and Eon Mini IPG
Eon and Eon Mini IPG Recalled for Battery Failure and Burn Injuries
St. Jude Medical, manufacturer of the Eon and Eon Mini Implantable Pulse Generator (IPG), has recalled thousands of the IPG devices due to serious injuries caused by battery issues.
Eon and Eon Mini Implantable Pulse Generators (IPG) are devices used to help manage chronic back pain through the use of electrical currents. The devices are implanted near the spine, providing spinal cord stimulation to help manage pain resulting from failed back surgery syndrome, severe nerve related pain, and other chronic pain syndromes.
EON AND EON MINI BATTERIES FAIL AND OVERHEAT
The Eon and Eon Mini IPG devices use a battery which must be charged every 24 hours.
According to the FDA, in some cases, the batteries would fail to keep their charge, preventing patients from access to pain relief. In other reported cases, the device would overheat while the patient was charging the battery, causing first and second degree burns.
PROBLEMS WITH EON AND EON MINI CHARGING SYSTEMS
- In 2011, St. Jude issued a recall on the Eon Mini after receiving 78 reports of battery issues.
- In July 2012, St. Jude issued a second recall, citing reports that 214 units had failed due to battery issues, putting patients at risk for serious burns and pain.
- Patients complained the device would not recharge, would not fully charge, suddenly lose power resulting in loss of pain relief, and heat up to the point of discomfort, pain, and injury.
- According to the FDA, 70,638 distributed units of the Eon and Eon Mini Charging Systems have been recalled to date. Model numbers recalled include:
- Eon (65-3716)
- Eon Mini (65-3788)
INJURIES ASSOCIATED WITH RECALLED EON AND EON MINI CHARGING SYSTEMS
- 1st degree burns
- 2nd degree burns
- Loss of charge, resulting in loss of pain relief
- Device removal (explant surgery)
- Complications with anesthesia