MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM; SCS LEAD

Model Number	102879
Medical Device Problem Codes	High impedance (1291); Intermittent Shock/Stimulation (2287)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported intermittent loss of stimulation.Disconnected electrodes were identified when the patient changed posture.Fluoroscopy identified that both leads were in close proximity, which could attribute to the identified intermittent disconnected electrodes.A revision procedure was completed and one of the implanted leads was removed.Intra-operative impedance check did not reveal any disconnected electrodes.During the initial programming visit three (3) days post revision procedure, disconnected electrodes were identified.No additional intervention has been reported to saluda at the time of this report.

• Brand Name: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• MDR Report Key: 21108698
• Report Number: 3016111136-2025-00003
• Device Sequence Number: 7947488
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2025
• Report Date (Section F): 12/13/2024

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: Health Professional
• Device Expiration Date: 03/11/2026
• Device Model Number: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9017072934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 03/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown