MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US); SCS LEAD

Model Number	102879
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported inadequate pain relief.X-ray imaging identified a lead migration.An impedance check was performed to identify high impedance.A lead revision procedure was completed to resolve the reported event and restore therapy.
Additional Manufacturer Narrative
Both leads were from the same lot.

• 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 ; AU 2113
• MDR Report Key: 22509976
• Report Number: 3016111136-2025-00101
• Device Sequence Number: 8736281
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025
• Report Date (Section F): 06/16/2025

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: 05/10/2025
• Device Model Number: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9015573947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 05/11/2023
• 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