MAUDE Adverse Event Report: Saluda Medical Pty Ltd Evoke CAP12 Percutaneous Lead Kit - 90cm (US); SCS Lead

Model Number	102879
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with the evoke spinal cord stimulation (scs) system reported pain at the midline incision.X-rays confirmed lead migration.Therapy remained adequate; however, the migrated lead bunched beneath the skin, causing significant discomfort.A lead revision was completed, and the midline incision site pain was substantially reduced, though post-operative pain persisted.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: Evoke CAP12 Percutaneous Lead Kit - 90cm (US)
• Common Device Name: SCS Lead
• Manufacturer (Section D): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50945208
• Report Number: 3016111136-2026-00201
• Device Sequence Number: 21439788
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/30/2026
• Report Date (Section F): 09/30/2026

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: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9018538428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/01/2026
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/07/2025
• 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: Female