MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	102880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Event or Problem Description
A patient was implanted with a trial evoke spinal cord stimulation (scs) system.The procedure and initial programming were completed without issue, and the patient was discharged.The saluda representative called the patient later that evening, and the patient reported significant improvement in pain.The following morning, the saluda representative was informed that the patient had died overnight.The cause of death is currently unknown and autopsy results are pending at the time of this report.
Additional Manufacturer Narrative
Additional information: section d4 - expiration date.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 lead was not returned to saluda.The patient had reported adequate pain relief following trial system implantation, and no device deficiencies or malfunctions were alleged.The cause of death remains unknown.The manufacturing records were reviewed and the product met all requirements for release.

• Brand Name: EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US)
• Common Device Name: SCS LEAD
• 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: 25092439
• Report Number: 3021836309-2026-00143
• Device Sequence Number: 9777733
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/01/2026

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: 102880
• Device Catalogue Number: 3016
• Device Lot Number: 9018271347
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2024
• 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: Death
• Patient Age: 47 YR
• Patient Sex: Female