MAUDE Adverse Event Report: Saluda Medical PTY LTD Evoke CAP12 Percutaneous Lead Kit - 90cm (US); SCS Lead

Model Number	102879
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with the evoke spinal cord stimulation (scs) system reported pain at the midline incision.X-rays confirmed lead migration.Therapy remained adequate; however, the migrated lead bunched beneath the skin, causing significant discomfort.A lead revision was completed, and the midline incision site pain was substantially reduced, though post-operative pain persisted.
Additional Manufacturer Narrative
The lead was not returned to saluda.The x-rays provided are consistent with lead migration.The root cause of the lead migration and pocket pain could not be definitively determined.The evoke scs system surgical guide identifies potential risks associated with surgery and spinal cord stimulation, including ¿lead migration or suboptimal placement, which may result in undesirable stimulation changes,¿ and states that ¿the patient may require surgery, including revision, explant, or replacement,¿ as a result.(b)(4).

• 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 ; 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: 50945206
• Report Number: 3021836309-2026-00296
• Device Sequence Number: 16059522
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 09/30/2026

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: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9018538428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/07/2025
• 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