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

Model Number	102901
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Lack of Effect (4065)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Implant Pain (4561)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported pain at the evoke closed loop stimulator (cls) implant site.The patient reported an unrelated trauma had occurred near the implant site, which may have contributed to the reported pain.Additionally, the patient reported inadequate pain relief since implantation.The evoke scs system was subsequently explanted.The evoke scs system was confirmed to be functioning as intended prior to the explant.
Additional Manufacturer Narrative
(b)(4).The evoke scs system was not returned to saluda.The root cause of the implant pain and inadequate pain relief could not be definitively determined; however, the unrelated trauma the patient experienced at the cls implant site may have contributed to the reported pain.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "temporary or persistent post-surgical pain at hardware implantation sites and inadequate pain relief following system implantation or over time and the patient may require surgery (including revision, explant, and replacement) as a result¿.

• 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: 50690242
• Report Number: 3021836309-2026-00271
• Device Sequence Number: 5891216
• Product Code: LGW
• UDI-Device Identifier: 09352307001572
• UDI-Public: 09352307001572
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/09/2026

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: 06/27/2026
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• 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: Unknown