MAUDE Adverse Event Report: Saluda Medical PTY LTD Evoke Closed Loop Stimulator (CLS) (US); SCS IPG

Model Number	102901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was hospitalized due to an infection at the evoke closed loop stimulator (cls) implant site.A washout procedure was performed and intravenous antibiotics were administered.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: section h6 - component code - previously reported as part/component/sub-assembly term not applicable (4755) updated to generator (825).Additional information: section d4 - expiration date, unique identifier (udi) #.Section g3 - date received by manufacturer.Section g6 - type of report.Section h4 - device manufacture date.Section h6 - evaluation codes.Section h11 - manufacturer narrative.The cls remains in use.The root cause of the infection could not be definitively determined.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "infection that may require hospitalisation with intravenous antibiotic therapy" and "the patient may require surgery (including revision, explant, and replacement)" as a result.The manufacturing records were reviewed and product met all requirements for release.(b)(4).

• 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 ; AS 2113
• Manufacturer (Section G): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50276783
• Report Number: 3021836309-2026-00249
• Device Sequence Number: 18571460
• Product Code: LGW
• UDI-Device Identifier: 09352307001572
• UDI-Public: 09352307001572
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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 Model Number: 102901
• Device Catalogue Number: 3042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2025
• 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; Hospitalization
• Patient Sex: Female