MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	102878
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for inadequate pain relief.An impedance check identified disconnected electrodes.Reprogramming was attempted but unsuccessful in restoring adequate therapy.A revision procedure was performed, and the leads were replaced to restore therapy and mri compatibility.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation has been completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
Section d - device returned to manufacturer; date returned to manufacturer.Section g - date received by manufacturer; type of report.Section h - evaluation codes.The leads could not be functionally tested, as they were received cut in half, which likely occurred during the revision procedure.Review of device logs confirmed disconnected electrodes.The root cause of the disconnected electrodes could not be definitively determined.The evoke scs system clinical manual details impedance as, "an electrode with a cross through it has high impedance (> 4000 o) and may be disconnected.A disconnected electrode shows an impedance of 8 and cannot be used for stimulation.Measurement electrodes that are disconnected will not record valid ecaps." 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." device information for both leads is identical.

• Brand Name: EVOKE CAP12 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: 24884426
• Report Number: 3021836309-2026-00114
• Device Sequence Number: 9897085
• Product Code: LGW
• UDI-Device Identifier: 09352307001640
• UDI-Public: 09352307001640
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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 Expiration Date: 04/18/2026
• Device Model Number: 102878
• Device Catalogue Number: 3008
• Device Lot Number: 9017277073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2024
• 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: Female