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

Model Number	101144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A saluda representative was requested to attend a device check visit prior to a patient scheduled to undergo magnetic resonance imaging (mri).During the visit, the patient reported that they had previously undergone a full system explant and were no longer implanted with an evoke scs system.Additional details regarding the event were not provided to the saluda representative.The explant procedure was performed by a different physician and at a different facility than those involved in the original implantation.
Additional Manufacturer Narrative
The event date was not reported.The date has been documented with an approximate date of 12november2025.Investigation of this event is in progress.Once the investigation has been completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: section d - expiration date.Section g - date received by manufacturer; type of report.Section h - device manufacture date; evaluation codes.The evoke scs system was discarded.The reason and specific details regarding the explant remain unknown.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "inadequate pain relief following system implantation or over time and the patient may require surgery (including revision, explant, and replacement) as 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 ; 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: 24966856
• Report Number: 3021836309-2026-00127
• Device Sequence Number: 10580766
• Product Code: LGW
• UDI-Device Identifier: 09352307001565
• UDI-Public: 09352307001565
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 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): 05/12/2026

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: 04/11/2025
• Device Model Number: 101144
• Device Catalogue Number: 3002
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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