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 Code	Limb Pain (4836)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a trial implant procedure for the evoke spinal cord stimulation (scs) system, the patient reported pain in their left lower limb.The leads were removed, and a magnetic resonance imaging (mri) scan was performed.No anomalies were detected in the mri scan and the patient was subsequently hospitalized.Three (3) days later, the patient reported their symptom had resolved, and the patient was discharged.
Additional Manufacturer Narrative
The leads were not returned to saluda.The root cause of the reported limb pain cannot be definitively determined.The evoke scs system surgical guide details potentials risks associated with surgery and spinal cord stimulation including, "abnormal sensations or pain." the manufacturing records were reviewed and the product met all requirements for release with no anomalies identified.Both leads implanted were from the same lot.

• 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: 23818047
• Report Number: 3021836309-2025-00380
• Device Sequence Number: 10098386
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 12/16/2025

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 Model Number: 102880
• Device Catalogue Number: 3016
• Device Lot Number: 9018102294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 10/07/2024
• 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: Unknown