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

Model Number	101144
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Implant Pain (4561)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cls and lead were discarded.The root cause of the cls migration and pain at the cls implant site, and inadequate pain relief cannot be definitively determined.The evoke scs system surgical guide details potential risks associated with the implantation and use of spinal cord stimulation system including, "temporary or persistent post-surgical pain at hardware implantation sites.Cls migration or suboptimal placement, which may result in pain or difficulty in charging, and the patient may require surgery (including revision, explant, and replacement) as a result; and also includes, uncomfortable changes in stimulation (over and/or under stimulation) and inadequate pain relief following system implantation or over time." lead information: brand name: evoke cap12 percutaneous lead kit: 60cm.Model: 102878.Catalog: 3008.Lot/batch number: 9015604946.Manufacture date: 17 may 2023.Expiration date: 16 may 2025.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported migration of the evoke closed loop stimulator (cls) along with pain at the cls implant site.The patient additionally reported inadequate pain relief.The physician¿s evaluation and x-ray imaging identified one lead was positioned too lateral, which contributed to the inadequate pain relief.A revision procedure was performed to replace the cls and lead and resolve the reported event.

• 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: 24470525
• Report Number: 3021836309-2026-00059
• Device Sequence Number: 9506686
• Product Code: LGW
• UDI-Device Identifier: 09352307001565
• UDI-Public: 09352307001565
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 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): 02/27/2026

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: 09/13/2025
• 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: 02/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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