| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00920-1 |
| Product Name/Description |
Brio Charging System Model 6721 (used with Deep Brain Stimulator, Brio IPG Model 65-6788)
ARTG Number: 164512 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Some patients have reported experiencing an uncomfortable temperature increase at the Implantable Pulse Generator (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 Brio LE Charging System Model 6722 and Brio LE Charger Accessory Model 6720 reduces 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 either charge for 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 Brio LE Charger Accessory Model 6720 must be confirmed. The Brio LE Charger System Model 6722 and Brio LE Charger Accessory Model 6720 may not be able to charge implanted IPGs at an implant depth greater than 2.25cm (the Model 6721 was labelled for implant depth up to 2.50 cm). In case of difficulties with the charging function of the Brio LE Charger Accessory Model 6720 due to the depth of the implant, patients should continue to use their current Brio Charger Model 6721, following the precautions provided in the August 2012 letter. |
| Contact Information |
(02) 9936 1200 - St Jude Medical |