The Eon Mini Implantable Pulse Generator recall
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…
Why was The Eon Mini Implantable Pulse Generator recalled?
Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Eon Mini - 3788 (IPG), Multiple Serial Numbers
- 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…
- Recalling firm
- Advanced Neuromodulation Systems Inc.
- Quantity
- 56 units
- Distribution
- US Nationwide Distribution
- Recall date
- October 17, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)