| TGA Action ID |
RC-2025-RN-00114-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Lead Kits
Lead Kit
Model number: LEAD1058-50(B), LEAD1058-70(B), LEAD1058-90(B)
Surgical Lead Kit
Model number: LEAD3005-70B
Surpass-C Surgical Lead Kit
Model number: LEAD2005-70B, LEAD2005-90B
ARTG's 284256, 185992, 368530 |
| ARTG Number |
185992, 284256, 368530 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The Instructions for Use (IFU) have been updated by the manufacturer to eliminate the Upper Limb and Neck (ULN) indication.
These updates have been made following the outcome of a post-market review conducted by the TGA. The review revealed that the long-term efficacy data for the Upper Limb and Neck (ULN) indication was insufficient.
No harm has been documented as a result of this problem. |
| Instructions for Customers/Users |
· Customers are requested to review the updated Instructions for Use (IFU).
· Customers should ensure that all relevant personnel and patients are provided with the latest IFU.
· The patient should be advised to consult their healthcare provider if they have concerns about the effectiveness of their therapy.
This action has been finalised on 3/9/2025. |
| Action Commencement Date |
28/05/2025 |
| Responsible Entity |
|
| Contact Information |
0499 800 192 - Daniel S Paul, Nevro Medical |