MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	102878
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for inadequate pain relief.Lead migration was confirmed via x-ray imaging.Reprogramming was unable to restore adequate therapy.A revision procedure was performed and the leads were replaced to restore therapy.It was noted that non-saluda anchors were used to secure the migrated leads.

• Brand Name: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)
• Common Device Name: SCS LEAD
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• MDR Report Key: 24755765
• Report Number: 3016111136-2026-00069
• Device Sequence Number: 21018634
• Product Code: LGW
• UDI-Device Identifier: 09352307001640
• UDI-Public: 09352307001640
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/01/2026
• Report Date (Section F): 03/09/2026

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: 102878
• Device Catalogue Number: 3008
• Device Lot Number: 9018216317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2024
• 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