MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE ACTIVE ANCHOR KIT; SCS ANCHOR

Model Number	102996
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient previously implanted with an evoke spinal cord stimulation (scs) system was evaluated for insufficient pain relief.Troubleshooting was performed, included reprogramming.X-rays show migration occurred.During the lead revision, repositioning was not available due to scar tissue, therefore; both leads were replaced restoring adequate pain relief.
Additional Manufacturer Narrative
Both leads are from the same lot.Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was discarded, making it unavailable for analysis.X-ray imaging confirmed the reported lead migration.Without the return of the device, it is not possible to reach a definitive root cause.The evoke scs system surgical guide details risks associated with surgery and spinal cord stimulation including, "lead migration or suboptimal placement, which may result in undesirable stimulation changes" and continues by stating, "the patient may require surgery (including revision, explant, and replacement)" as a result.

• Brand Name: EVOKE ACTIVE ANCHOR KIT
• Common Device Name: SCS ANCHOR
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw - ; AU -
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw - ; AU -
• MDR Report Key: 21827890
• Report Number: 3021836309-2025-00094
• Device Sequence Number: 9280983
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2026
• Device Model Number: 102996
• Device Catalogue Number: 3043
• Device Lot Number: 9016723709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown