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
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
• MDR Report Key: 24470523
• Report Number: 3016111136-2026-00043
• Device Sequence Number: 9361018
• Product Code: LGW
• UDI-Device Identifier: 09352307001565
• UDI-Public: 09352307001565
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026
• Report Date (Section F): 02/06/2026

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female