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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 St Jude Medical Australia Pty Ltd
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
Contact Information 03 9644 5909 - St Jude Medical Neuromodulation Division