Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Systems
Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation Systems due to reports of warmth or heating at the implant site during charging.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of physical symptoms (warmth/heating) at the implant site, which aligns with the rubric criteria for Severe severity involving significant injury reports or Class II classifications with adverse health consequences.
Plain-English summary
Advanced Neuromodulation Systems Inc. is recalling the Eon Mini Neurostimulation (IPG) System (Model 3788). This is a 16-channel, rechargeable, multi-program system indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs. The recall covers 30,560 units distributed nationwide within the US and internationally to numerous countries including Argentina, Australia, Canada, and the United Kingdom.
The recall was initiated due to patient complaints of warmth or heating at the implantable pulse generator (IPG) implant site during charging. As of November 30, 2011, St. Jude Medical had received 116 reports of these symptoms specifically for the Eon Mini IPG, in addition to 110 reports for the Eon IPG. The agency has classified this recall as Class II.
Patients with these implanted devices should contact their healthcare provider for instructions on managing the device and addressing the reported heating symptoms.
The recalled product
- Product
- The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid i
- Manufacturer
- Advanced Neuromodulation Systems Inc.
- Hazard
- Affected units
- 30,560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots of Eon Mini (Product Code 65-3788)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Advanced Neuromodulation Systems Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Advanced Neuromodulation Systems Inc.
See all →- HighBrio DBS implantable pulse generators recalled for unintended fluid ingress
FDA (Devices) · 2013-03-06
- HighAdvanced Neuromodulation Systems Recalls Eon Mini Implantable Pulse Generators
FDA (Devices) · 2012-10-17
- SevereAdvanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints
FDA (Devices) · 2012-09-05
- SevereAdvanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices
FDA (Devices) · 2012-07-18
Same hazard · heating
See all →- HighGE Healthcare Recalls SIGNA Creator and Explorer MRI Devices
FDA (Devices) · 2016-09-14
- HighSt. Jude Medical Recalls Eon and Eon Mini Charging Systems
FDA (Devices) · 2013-07-31
- SevereSt. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems
FDA (Devices) · 2013-07-24
- SevereSt. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers
FDA (Devices) · 2013-07-24
- SevereMedrad Recalls DC Power Cables for Veris MR Vital Signs Monitor
FDA (Devices) · 2013-07-03