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

Model Number	102996
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Both leads are from the same lot.
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
Correction: section d.1 - brand name.2 - common device name.4 - model #, lot, catalog#.Section f: 10 - component code.Additional information: section d: 4 - expiration date, unique identifier (udi) #.Section f: 6 - uf/importer event awareness date.7 - type of report, follow-up #.8 - date of this report.10 - medical device problem code.Section h: 4 - device manufacture date.

• 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
• MDR Report Key: 21827891
• Report Number: 3016111136-2025-00050
• Device Sequence Number: 21152449
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025
• Report Date (Section F): 03/14/2025

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• 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 This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown