| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00784-3 |
| Product Name/Description |
Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)
Eon Mini
Product Code: 65-3788
ARTG Number: 154912
Brio IPG
Product Code: 65-6788
ARTG Number: 164510 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
This is an update to the 'Hazard Alert' letter dated 24 May 2011, pertaining to the Eon Mini Model 3788 and Brio Model 6788 implantable pulse generators (IPGs) inner battery cracking issues. St. Jude Medical received reports Eon Mini and Brio IPGs that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please refer to the TGA Website http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm |
| Contact Information |
03 9644 5909 - St Jude Medical Neuromodulation Division Manager |