MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CLOSED LOOP STIMULATOR (CLS) (US); SCS IPG

Model Number	101144
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/03/2026
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 and anchor implant site.The evoke scs system was explanted to resolve the reported event.The evoke scs system was confirmed to be functioning as intended prior to the explant.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation has been completed, a supplemental report will be submitted.Anchor information: brand name: evoke active anchor kit.Model: 102996.Catalog: 3043.Lot/batch number: 9014868277.Udi: (b)(4).
Additional Manufacturer Narrative
Additional information: section d - expiration date; date returned to manufacturer; device returned to manufacturer.Section g - date received by manufacturer; type of report.Section h - device manufacture date; evaluation codes.The cls, leads and anchors were returned to saluda.The cls and anchors passed visual inspection, with no anomalies observed.The root cause of the pain at the cls implant site and anchor site couldn't be definitively determined.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 abnormal sensations or pain and the patient may require surgery (including revision, explant, and replacement) as a result".Anchor information: manufacture date: 05january2023.Expiration date: 04january2025.

• 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 ; 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: 24639725
• Report Number: 3021836309-2026-00083
• Device Sequence Number: 9895040
• Product Code: LGW
• UDI-Device Identifier: 09352307001565
• UDI-Public: 09352307001565
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 08/15/2025
• Device Model Number: 101144
• Device Catalogue Number: 3002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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