| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00759-3 |
| Product Name/Description |
Eon, Eon Mini and Brio Implantable Pulse Generator (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)
Eon Implantable Pulse Generator (IPG)
Product Code 64-3716
ARTG Number: 127126
Eon Mini IPG
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 |
9/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Reports of heating at the IPG implantation site during charging of the Spinal cord and Deep Brain stimulators. This is an update to the 'Hazard Alert' letter dated 05 January 2012 . In the updated letter, St. Jude is providing updated occurrence rates, informing hospitals and treating clinicians of four instances of patient burns associated with charging the IPGs and additional patient management recommendations. |
| 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 see http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm |
| Contact Information |
03 9644 5909 - St Jude Medical Neuromodulation Division |