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

Model Number	101144
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to saluda for analysis.The root cause of the reported inadequate pain relief cannot be definitively determined.The evoke scs system was confirmed to be operating as intended.The evoke scs system surgical guide states ¿the risks associated with the implantation and use of a spinal cord stimulation system include: inadequate pain relief following system implantation and the patient may require surgery (including revision, explant, and replacement) as a result.¿.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system requested a system explant due to inadequate pain relief.The saluda representative confirmed that the patient had been implanted for 14 months, during which time there were multiple attempts to troubleshoot and program the patient¿s device with minimal pain relief achieved.The evoke scs system was confirmed to be operating as intended.

• Brand Name: EVOKE CLOSED LOOP STIMULATOR (CLS)
• 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: 21358961
• Report Number: 3021836309-2025-00031
• Device Sequence Number: 8437464
• Product Code: LGW
• UDI-Device Identifier: 09352307000292
• UDI-Public: 09352307000292
• Combination Product (Y/N): N
• 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: 2024
• 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): 02/12/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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