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	Hematoma (1884); Pain (1994); Paresis (1998)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lead was not returned to saluda.The root cause of the reported event cannot be definitively determined.The evoke scs system surgical guide states, ¿the risks associated with the implantation and use of a spinal cord stimulation system include hematoma at surgery sites and temporary or persistent post-surgical pain at hardware implantation sites as well as weakness, clumsiness, numbness, abnormal sensations or pain.¿ the manufacturing records were reviewed, and the product met all requirements for release with no anomalies identified.
Event or Problem Description
A patient implanted with a trial evoke spinal cord stimulation (scs) system reported severe pain and impaired mobility a day after the trial implant procedure.Evaluation in the emergency department identified a hematoma.The trial leads were removed, and the patient was hospitalized.A magnetic resonance imaging (mri) and computed tomography (ct) scans were performed.The physician did not observe any factors during the procedure that could have contributed to the reported event, and a dural puncture was not suspected.The reported event persisted following the removal of trial leads.

• 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
• 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: 23605149
• Report Number: 3021836309-2025-00339
• Device Sequence Number: 9258833
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• 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: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 08/20/2026
• Device Model Number: 102880
• Device Catalogue Number: 3016
• Device Lot Number: 9017877875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 08/20/2024
• 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; Hospitalization
• Patient Sex: Male