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

Model Number	102901
Medical Device Problem Codes	Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported undesirable increase in stimulation following an abdominal surgery.Electrocautery use was reported during the procedure.During an impedance check, the patient reported unintended occurrence of stimulation.Increased artifacts were observed, and difficulty obtaining ecap was noted during the reprogramming attempt.These observations did not exist during visits prior to the abdominal surgery.A revision procedure was performed and the evoke closed loop stimulator (cls) was replaced.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.

• 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: 50252185
• Report Number: 3021836309-2026-00238
• Device Sequence Number: 18687803
• Product Code: LGW
• UDI-Device Identifier: 09352307001572
• UDI-Public: 09352307001572
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 09/22/2026

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: 07/21/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2025
• 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
• Patient Sex: Male