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

Model Number	102879
Medical Device Problem Codes	High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system underwent an impedance check, which identified a disconnected electrode impacting the system¿s magnetic resonance imaging (mri) compatibility.The patient required an mri, and a lead replacement was planned to restore the evoke scs mri compatibility.During the lead revision procedure, the patient experienced a drop in blood pressure, and the procedure couldn¿t be completed as planned.As a result, the evoke scs system was explanted instead of proceeding with the planned lead replacement.
Additional Manufacturer Narrative
The lead was not returned to saluda.Impedance logs were reviewed, which confirmed the reported disconnected electrode.The root cause of the disconnected electrode or the patients drop in blood pressure could not be definitively determined.The evoke scs system mri guidelines include the following 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.¿.

• Brand Name: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (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: 23976134
• Report Number: 3021836309-2026-00002
• Device Sequence Number: 4786574
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2025
• 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): 01/06/2026

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: 07/12/2026
• Device Model Number: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9017689008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 07/12/2024
• 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: Male