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
Additional Manufacturer Narrative
The lead was discarded and not returned to saluda for analysis.A review of device logs from the event date confirmed a high impedance.A review of device logs from the initial programming visit on (b)(6) 2024 post revision procedure did not reveal any disconnected electrode.The reported event of disconnected electrode could not be confirmed, and the cause of high impedance could not be definitively determined.The evoke scs system surgical guide states "the risks associated with the implantation and use of a spinal cord stimulation system include undesirable changes in stimulation and the patient may require surgery (including revision, explant, and replacement) as a result.¿.
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
• 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: 21107796
• Report Number: 3021836309-2025-00007
• Device Sequence Number: 12768238
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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: Other
• Patient Sex: Unknown