MAUDE Adverse Event Report: Saluda Medical Pty Ltd Evoke Closed Loop Stimulator (CLS) (US); SCS IPG

Model Number	102901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for a systolic blood pressure below 100.No signs or symptoms of an infection were identified during evaluation; however, the physician suspected a possible infection related to the evoke scs system.No additional intervention was performed due to absence of signs or symptoms of infection.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: Evoke Closed Loop Stimulator (CLS) (US)
• Common Device Name: SCS IPG
• Manufacturer (Section D): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50753363
• Report Number: 3016111136-2026-00189
• Device Sequence Number: 18506870
• Product Code: LGW
• UDI-Device Identifier: 09352307001572
• UDI-Public: 09352307001572
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026
• Report Date (Section F): 09/14/2026

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: 102901
• Device Catalogue Number: 3042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/20/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female