MAUDE Adverse Event Report: Saluda Medical Pty Ltd Evoke CAP12 Percutaneous Lead Kit - 60cm (US); SCS LEAD

Model Number	102878
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury

• 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 ; AS 2113
• MDR Report Key: 50861026
• Report Number: 3016111136-2026-00198
• Device Sequence Number: 10025582
• Product Code: LGW
• UDI-Device Identifier: 09352307001640
• UDI-Public: 09352307001640
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026
• Report Date (Section F): 09/22/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• 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