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

Model Number	102901
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system requested a system explant due to inadequate pain relief and disliking the stimulation sensation.The patient additionally reported that they were experiencing phantom leg pain and the pain would increase during stimulation.During the patient¿s trial period and following the permanent implantation, the patient reported that adequate pain relief was achieved.The evoke scs system was explanted to resolve the reported event.
Additional Manufacturer Narrative
(b)(4).Investigation of this event is in progress.Once the investigation has been completed, a supplemental report will be submitted.

• 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
• Manufacturer (Section G): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50842412
• Report Number: 3021836309-2026-00283
• Device Sequence Number: 10262828
• Product Code: LGW
• UDI-Device Identifier: 09352307001572
• UDI-Public: 09352307001572
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/21/2026

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
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male