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.The leads were not returned to saluda.The root cause of the reported event cannot be definitively determined.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "temporary or persistent post-surgical pain at hardware implantation sites" and "erosion of the implanted components through the skin and the patient may require surgery (including revision, explant, and replacement) as a result.¿.
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
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw - ; AU -
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw - ; AU -
• MDR Report Key: 23727089
• Report Number: 3021836309-2025-00355
• Device Sequence Number: 13424167
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• 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: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2025
• 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