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

Model Number	EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM (US)
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported their scs system program was no longer working.It was identified that the system had disconnected electrodes.The patient's system was reprogrammed with two closed-loop programs.The programs did not provide the stability desired, so the patient underwent a revision procedure.All impedances were in range and the patient's therapy was restored following the procedure.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 18440048
• Report Number: 3016111136-2024-00139
• Device Sequence Number: 20591488
• Product Code: LGW
• UDI-Device Identifier: 09352307000087
• UDI-Public: 09352307000087
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2024
• Report Date (Section F): 12/12/2023

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: 08/03/2023
• Device Model Number: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM (US)
• Device Catalogue Number: 3008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2024
• Date Device Manufactured: 10/10/2022
• 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