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

Model Number	101144
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Unspecified Musculoskeletal problem (4535)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system requested a system explant due to inadequate pain relief since implantation.It was noted that the patient received adequate relief during the trial period.Troubleshooting was performed, including reprogramming, without resolution.An x-ray was performed with no device issues identified.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.Following the explant procedure, the patient reported that their condition had worsened.The patient developed new, progressive spinal pathology.An x-ray obtained on (b)(6) 2025, identified a new disc herniation located at the l2-3, causing left sided lumbar radiculopathy.On (b)(6) 2025, the patient¿s condition had reportedly deteriorated to a large l2-3 disc extrusion with left hip and groin radiculopathy.A transforaminal lumbar interbody fusion (tlif) at the l2-3 was performed in (b)(6) 2025, followed by extensive rehabilitation.

• 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: 24688193
• Report Number: 3016111136-2026-00060
• Device Sequence Number: 21307983
• Product Code: LGW
• UDI-Device Identifier: 09352307001565
• UDI-Public: 09352307001565
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2026
• Report Date (Section F): 03/06/2026

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: 01/03/2026
• 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: 03/06/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• 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: Male