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

Model Number	102879
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient has two (2) evoke percutaneous leads implanted which cannot be distinguished.The 2nd lead details are below: product description: evoke cap12 percutaneous lead kit - 90cm.Model # : 102879.Catalog#: 3009.Serial/lot #: (b)(6).Manufacture date: 09dec2022.Expiration date: 08dec2024.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for skin perforation at the lead implant site.The evoke scs system was explanted, and antibiotics were prescribed.

• 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: 23727079
• Report Number: 3016111136-2025-00205
• Device Sequence Number: 10595743
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/05/2025
• Report Date (Section F): 11/11/2025

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: 01/11/2025
• Device Model Number: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9014926319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/11/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 01/12/2023
• 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: Male