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

Model Number	101144
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Death
Event or Problem Description
A saluda representative was notified by a study coordinator that the patient had passed away.The study coordinator reported that, upon attempting to contact the patient to schedule their 6-month follow-up visit, they were informed of the patient¿s death.Additional details regarding the event have not been provided to saluda.
Additional Manufacturer Narrative
The evoke scs system was not returned to saluda.Further details of the patient¿s death have not been disclosed to saluda.The root cause of the patient¿s death could not be definitively determined.There was no allegation of device deficiency prior to the patient¿s death.The event date was not provided.Therefore, 14 january 2026 has been selected as the event date, corresponding to the date saluda was notified of the event.
Event or Problem Description
The patient reported feeling unwell and was hospitalized on (b)(6) 2025, subsequently requiring transfer to the intensive care unit for management of septic shock.The patient required endotracheal intubation and mechanical ventilation.A pulse was not detected in the left radial artery.A chest ct revealed extensive bilateral multifocal pneumonia.The patient¿s clinical condition continued to deteriorate, and she was transferred to (b)(6) hospital for higher level care.On arrival, she remained tachycardic and hypotensive, with severe metabolic and respiratory acidosis.A repeat chest ct revealed right lower lobe and partial right upper lobe pneumonia.The patient remained intubated and sedated.The patient ultimately experienced cardiac arrest, which was determined to be the cause of death.The physician reported primary cause of death as cardiac arrest with secondary cause as septic shock (hcc), acute kidney injury, right lower lobe pneumonia, uti, nodule of left lung, hypotension, leukocytosis, lactic acidosis, and diminished pulse in upper extremity.The patient was enrolled in the neural panel study, which is a post-market study.
Additional Manufacturer Narrative
Correction: section b - date of death.Section e - initial reporter.Additional information: section a - sex, date of birth.Section b - date of event; event description; medical history/preexisting condition.Section g - date received by manufacturer; type of report.Section h - evaluation codes.The evoke scs system was discarded.The patient's primary cause of death was due to cardiac arrest.The secondary cause had a variety of issues listed, which the physician noted contributed to the patient's death.There was no allegation of device deficiency prior to the patient's death.

• 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: 24246668
• Report Number: 3021836309-2026-00027
• Device Sequence Number: 8402819
• Product Code: LGW
• UDI-Device Identifier: 09352307001565
• UDI-Public: 09352307001565
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 08/15/2025
• 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): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• 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: Death
• Patient Age: 74 YR
• Patient Sex: Female