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EON Neurostimulation System and EON Mini Neurostimulation System
- Starting date:
- December 19, 2011
- Posting date:
- January 23, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-26257
Recalled Products
- EON Neurostimulation System – Implantable Pulse Generator
- EON Mini Neurostimulation System – Implantable Pulse Generator
Reason
There is potential for warmth or heating at the IPG implant site during charging. The rate of occurrence is low, however in some situations, the issue LED to explant/revision of the implanted device.
Affected products
A. EON Neurostimulation System – Implantable Pulse Generator
Lot or serial number
- N/A
Model or catalog number
- 3716
Companies
- Manufacturer
- Advanced Neuromodulation Systems, Inc.
B. EON Mini Neurostimulation System – Implantable Pulse Generator
Lot or serial number
- N/A
Model or catalog number
- 3788
Companies
- Manufacturer
- Advanced Neuromodulation Systems, Inc.