MAUDE Adverse Event Report: Saluda Medical PTY LTD Evoke CAP12 Percutaneous Lead Kit - 60cm (EU MDR); SCS LEAD

Model Number	103112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with a trial evoke spinal cord stimulation (scs) system was evaluated in the emergency department for severe headaches.A dural puncture was suspected to have occurred during the trial lead placement procedure.The patient underwent a blood patch procedure and the trial leads were removed.
Additional Manufacturer Narrative
The leads were not returned to saluda.The root cause of the cerebrospinal fluid leakage could not be definitively determined.The evoke scs system surgical guide lists cerebrospinal fluid (csf) as a potential risk associated with the implantation and use of a spinal cord stimulation system.

• Brand Name: Evoke CAP12 Percutaneous Lead Kit - 60cm (EU MDR)
• Common Device Name: SCS LEAD
• Manufacturer (Section D): Saluda Medical PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer (Section G): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50455345
• Report Number: 3021836309-2026-00252
• Device Sequence Number: 13077239
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 08/26/2026

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: 103112
• Device Catalogue Number: 1008
• Device Lot Number: 9019692003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• 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