MAUDE Adverse Event Report: Saluda Medical PTY LTD Evoke CAP12 Percutaneous Lead Kit - 60cm (US); SCS LEAD

Model Number	102878
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient previously implanted with an evoke spinal cord stimulation (scs) system was evaluated for a change in stimulation.X-rays confirmed lead migration.A lead revision was completed by repositioning both leads.
Additional Manufacturer Narrative
The lead was not returned to saluda.The root cause of the lead migration could not be definitively determined.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "lead migration or suboptimal placement, which may result in undesirable stimulation changes" and "the patient may require surgery (including revision, explant, and replacement)" as a result.Both leads are from the same lot.(b)(4).

• 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 ; AS 2113
• Manufacturer (Section G): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50718153
• Report Number: 3021836309-2026-00266
• Device Sequence Number: 16112393
• Product Code: LGW
• UDI-Device Identifier: 09352307001640
• UDI-Public: 09352307001640
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/10/2026

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: 102878
• Device Catalogue Number: 3008
• Device Lot Number: 9018216324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 10/29/2024
• 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