MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS IPG

Model Number	EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
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	10/02/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2.Date of death - date of death was not able to be obtained.Aware date was used.
Event or Problem Description
During a routine follow-up, saluda personnel was notified by a patient¿s spouse that the patient died.The cause of death was confirmed to be cancer and not related to the patient¿s evoke spinal cord stimulation (scs) system.The date of death was not provided.Saluda was not able to obtain further information.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS IPG
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• MDR Report Key: 20520967
• Report Number: 3016111136-2024-00025
• Device Sequence Number: 8701460
• Product Code: LGW
• UDI-Device Identifier: 09352307000292
• UDI-Public: 09352307000292
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024
• Report Date (Section F): 10/02/2024

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: Lay User/Patient
• Device Expiration Date: 04/04/2025
• Device Model Number: EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
• Device Catalogue Number: 3002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2024
• Event Location: Other
• Date Report to Manufacturer: 10/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Date Device Manufactured: 05/25/2023
• 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 Sex: Male