| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01279-1 |
| Product Name/Description |
Eon Mini Implantable Pulse Generator (IPG) Model 65-3788 and Eon Mini Charging System Model 3721
ARTG Number: 154912 and 158524 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/12/2014 |
| 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 Mini LE Charging System Model 3722 and Eon Mini LE Charger Model 3720 reduce the potential for uncomfortable temperature increases that may be felt near the IPG while recharging by automatically turning the energy it delivers on and off. This will require patients to charge longer or more frequently to achieve a full charge. |
| Recall Action |
Recall |
| Recall Action Instructions |
St. Jude Medical recommends 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 Mini LE Charger Model 3720 must be confirmed. The Eon Mini LE Charging System Model 3722 and Eon Mini LE Charger 3720 may not be able to charge implanted IPGs at an implant depth greater than 2.25cm (the Model 3721 was labelled for implant depth up to 2.50cm). In case of difficulties with the charging function of the Eon Mini LE Charger Model 3720 due to the depth of the implant, patients should continue to use their current Eon Mini Charging System Model 3721 following the precautions provided in the August 2012 letter. This action has been closed-out on 04/04/2017. |
| Contact Information |
02 9936 1200 - St. Jude Medical Australia |