Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices
Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation devices due to a workmanship issue that can cause loss of communication or recharging, resulting in loss of pain relief.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 a significant injury risk, specifically the loss of pain relief and the subsequent need for surgical explantation of the implanted device.
Plain-English summary
Advanced Neuromodulation Systems Inc. is recalling the Eon Mini Neurostimulation (IPG) System (Model 3788). The recall affects 25,255 devices manufactured prior to September 20, 2010. These devices are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome and intractable low back and leg pain.
The firm received 112 complaints regarding the devices losing the ability to communicate or recharge. The company determined that the cause is a workmanship issue related to process variances in the positioning of the internal battery and printed circuit board. This misalignment causes a short circuit, leading to premature depletion of the battery and subsequent loss of pain relief, which may require the device to be explanted.
The affected devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Argentina, Australia, Austria, Belgium, Brazil, Canada, and others. Patients with these devices should contact their healthcare provider for evaluation and management of the device status.
The recalled product
- Product
- Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low…
- Manufacturer
- Advanced Neuromodulation Systems Inc.
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 (2)
- Model Number 3788. All lots manufactured prior to September 20
- 2010.
Distribution
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