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	Unspecified Infection (1930); Pain (1994)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two (2) leads were used in the trial procedure.Below is the 2nd lead information: product description: evoke cap12 trial percutaneous lead kit - 60cm.Model #: 102880, catalog#: 3016, serial/lot #: (b)(6), udi: (b)(4).Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Event or Problem Description
Following the evoke spinal cord stimulation (scs) system trial, the patient's caregiver reported the patient was experiencing pain.During evaluation in the emergency department, infection was identified and antibiotics were prescribed.Diagnostics & ultrasound scan identified a kidney stone obstructing the kidney, which may have contributed to the infection.Patient is currently in the intensive care unit (icu).
Additional Manufacturer Narrative
The leads were returned to saluda.A root cause for the infection could not be definitive determined.The patient's history of kidney stones and uti's may have been a contributing factor.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "infection that may require hospitalisation with intravenous antibiotic therapy" and "abnormal sensations or pain." the manufacturing records were reviewed and the product met all requirements for release.
Event or Problem Description
It was further reported that the patient has been discharged from the hospital.

• 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: 23836497
• Report Number: 3021836309-2025-00390
• Device Sequence Number: 5032158
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/19/2026

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 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): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Other
• Patient Sex: Male