Advanced Neuromodulation Systems Recalls Eon Mini Implantable Pulse Generators
Advanced Neuromodulation Systems is recalling 56 Eon Mini Implantable Pulse Generators manufactured in April 2012 due to a potential internal battery contact issue that could cause painful stimulation surges.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (painful stimulation surges) in a medical device, but the source text does not report any actual injuries, hospitalizations, or deaths, fitting the criteria for a High severity score.
Plain-English summary
Advanced Neuromodulation Systems Inc. is recalling 56 units of the Eon Mini Implantable Pulse Generator (IPG) manufactured in April 2012. The Eon Mini IPG is a 16-channel, rechargeable, multi-program system used as an aid in the management of chronic intractable pain of the trunk and/or limbs. The affected devices are identified by the code Eon Mini - 3788 (IPG) and have multiple serial numbers.
The recall was initiated after routine testing, monitoring, and analysis of manufacturing processes identified that the internal battery in three lots of these devices has the potential to come into contact with the internal microcontroller board. This contact could potentially cause a sudden, brief surge in electrical stimulation, which would be felt by the patient as uncomfortable or painful.
The affected devices were distributed nationwide in the United States. Patients using these devices should contact their healthcare provider or Advanced Neuromodulation Systems Inc. for further instructions regarding the recall and potential replacement or repair of the device.
The recalled product
- Product
- The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectron
- Manufacturer
- Advanced Neuromodulation Systems Inc.
- Affected units
- 56
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)
- Eon Mini - 3788 (IPG)
- Multiple Serial Numbers
Distribution
Distributed nationwide across the United States.
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