| TGA Action ID |
RC-2026-RN-00572-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
WaveWriter Alpha Spinal Cord Stimulation (SCS) System
Material Numbers: M365SC14160, M365SC14320, M365SC12160, M365SC12320 |
| ARTG Number |
400292, 400373, 400374, 400392 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Boston Scientific is notifying customers of an update to the Information for Prescribers and Information for Patients manuals used in Australia for applicable Boston Scientific WaveWriter Alpha Spinal Cord Stimulation (SCS) System implantable components.
Following a review by the Therapeutic Goods Administration (TGA), Boston Scientific is updating SCS System labelling containing device lifetime statements to clarify that the clinical performance and safety of the implantable components have been demonstrated for 3 years. |
| Instructions for Customers/Users |
Customers are to:
- Refer to the updated Information for Prescribers and Information for Patients manuals when they become available.
Devices that have already been implanted do not require prophylactic replacement, additional patient follow-up, or any change in clinical management solely as a result of this notification. |
| Action Commencement Date |
5/08/2026 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com - Boston Scientific |