MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	101345
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system underwent a device check prior to a magnetic resonance imagery (mri).Disconnected electrode was identified and the patient requested a system explant to restore mri compatibility.At the time of this report, no additional information on the explant procedure is available to saluda.Saluda representatives are not expected to be consulted further on this event.
Additional Manufacturer Narrative
The lead was not returned to saluda.Device logs were reviewed and confirmed an electrode disconnection.A root cause for the electrode disconnection could not be definitively determined.The evoke scs system mri guidelines includes the warning, "mri compatibility has not been determined for a system where the impedance of the lead shows disconnected or shorted channels.Impedance measurement must be performed to ensure no channels are disconnected or shorted prior to scanning." section d4 serial number ¿ the serial number of the lead with disconnected electrode could not be determined.Two leads were implanted and the device information is provided below: lead1: product description: evoke 12c percutaneous lead kit - 60 cm.Serial/lot #: (b)(6).Manufacture date: 11/25/2022.Expiration date: 9/20/2023.Lead 2: product description: evoke 12c percutaneous lead kit - 60 cm.Serial/lot #: (b)(6).Manufacture date: 11/25/2022.Expiration date: 9/20/2023.

• Brand Name: EVOKE 12C 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: 24965462
• Report Number: 3021836309-2026-00126
• Device Sequence Number: 21439631
• Product Code: LGW
• UDI-Device Identifier: 09352307000087
• UDI-Public: 09352307000087
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/23/2026

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: 101345
• Device Catalogue Number: 3008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• 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: Female