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.
Additional Manufacturer Narrative
The evoke scs system was not returned to saluda.The most recent available device logs with patient therapy data, captured from a programming session on (b)(6) 2024, were reviewed.Multiple instances of ¿stop for possible noise closed loop¿ errors were noted.It was identified that the patient was not manually ending stimulation prior to charging, resulting in the observed error and the cls automatically ending stimulation.Evoke scs system user manual cautions ¿turn therapy off before you start charging.You may experience increases or decreases in therapy strength if you start charging while therapy is on.You may turn therapy on once charging has started.However, closed-loop stimulation is disabled during charging.You may experience increases or decreases in therapy strength.In some cases, the therapy may stop during charging¿.Review of impedance logs did not identify disconnected electrodes and all impedances were observed to be within programmable range.The root cause of the reported inadequate pain relief cannot be definitively determined.The evoke scs system surgical guide details the potential risks associated with the implantation and use of a spinal cord stimulation system, including ¿inadequate pain relief following system implantation and the patient may require surgery (including revision, explant, and replacement) as a result.¿ the manufacturing records were reviewed, and the product met all requirements for release.

• 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: 24688188
• Report Number: 3021836309-2026-00087
• Device Sequence Number: 9855171
• Product Code: LGW
• UDI-Device Identifier: 09352307001565
• UDI-Public: 09352307001565
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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: Male