| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00460-1 |
| Product Name/Description |
Eon Wall Charger Model 3701 and Eon Portable Charger Model 3711 (Implantable pulse generator chargers)
ARTG Number: 127126 and 154792 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Some patients have reported experiencing an uncomfortable temperature increase at the IPG implant site during charging, with a small number of patients reporting burns at the implant site. This matter is a follow-up to a Hazard Alert letter issued by St. Jude Medical (SJM) in August 2012 (TGA Reference: RC-2012-RN-00759-3).
In the August 2012 letter, St. Jude Medical informed customers that they would be implementing design improvements to the charger to address the possibility of increased energy dissipation during charging. The new Eon Charging System Model 3726 reduces the potential for uncomfortable temperature increases that may be felt near the spinal cord stimulator while recharging by automatically turning the energy it delivers on and off to reduce the rise in temperature of the spinal cord stimulator and of the charger wand during charging. |
| Recall Action |
Recall |
| Recall Action Instructions |
St. Jude Medical is recommending to implanting physicians for the prompt replacement of the charger for patients who have reported excessive heating during charging. For other patients, replacement of the charger is recommended at the next follow up. Upon replacement, proper charging function of the Eon Charging System Model 3726 should be confirmed. Until such time that patients have had their chargers replaced, patients should be advised to continue to use their current Eon Mini Charging System following the precautions provided in the August 2012 letter. This action has been closed-out on 09/08/2016. |
| Contact Information |
02 9936 1200 - St Jude Medical Representative |