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	Pain (1994)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lead was not returned to saluda.A root cause for the reported pain could not be definitively determined; however, the lead placement may have resulted in nerve irritation due to anatomical challenges.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "weakness, clumsiness, numbness, abnormal sensations or pain" and "epidural hemorrhage, spinal cord injury, possible paralysis or other neurological complications" as a result.The manufacturing records were reviewed and the product met all requirements for release.
Event or Problem Description
During implantation of a trial evoke spinal cord stimulation (scs) system, the physician encountered difficulty placing the leads due to patient anatomical challenges.One lead was successfully implanted.The patient reported severe pain while in the post-anesthesia care unit (pacu) and requested lead removal.Intravenous (iv) fentanyl and toradol were administered and the patient was discharged.The physician attributed the patient¿s symptoms to nerve irritation that may have occurred during lead placement.

• 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: 25531237
• Report Number: 3021836309-2026-00189
• Device Sequence Number: 13197513
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 06/17/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 11/18/2024
• 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
• Patient Sex: Female