MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	102880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880); Nausea (1970); Neck Pain (2433)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the trial period of the evoke spinal cord stimulation (scs) system, the patient presented to the emergency department with headache, nausea, and neck pain.The trial leads were removed.Magnetic resonance imaging (mri) identified a cerebrospinal fluid (csf) leak.A blood patch procedure was performed.At the time of reporting, the patient's symptoms were reported to be resolving.

• Brand Name: EVOKE CAP12 TRIAL 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 ; AU 2113
• MDR Report Key: 25056286
• Report Number: 3016111136-2026-00094
• Device Sequence Number: 9427280
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2026
• Report Date (Section F): 04/08/2026

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: 102880
• Device Catalogue Number: 3016
• Device Lot Number: 9018317993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2026
• 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