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

Model Number	104523
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Burning Sensation (2146); Inadequate Pain Relief (2388); Implant Pain (4561)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cls information: brand name: evoke closed loop stimulator (cls) (us) model: 102901 catalog: 3042 lot/batch number: 210d70 udi: (b)(4).
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported a burning sensation at the evoke closed loop stimulator (cls) implant site and a change in stimulation.The burning sensation resolved when stimulation was turned off; however, tenderness at the cls implant site was reported upon palpation.Magnetic resonance imaging (mri) did not identify an infection.No anomalies were observed during the impedance check.X-rays identified lead migration.Reprogramming was attempted but did not resolve the reported issue.A revision procedure was performed, and the evoke scs system was replaced to resolve the reported event.

• Brand Name: DIRECT CLAMP 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: 25664613
• Report Number: 3016111136-2026-00139
• Device Sequence Number: 10379384
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026
• Report Date (Section F): 06/04/2026

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 Model Number: 104523
• Device Catalogue Number: 3043
• Device Lot Number: 9018216303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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