MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE ACTIVE ANCHOR KIT (US); SCS ANCHOR

Model Number	102996
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported inadequate pain relief after a motor vehicle accident.The implanted leads were reported to have migrated.A revision procedure was completed and therapy was restored.
Additional Manufacturer Narrative
Additional information: section d6b.- explantation date.Section g3 - date received by manufacturer.Section g6 - type of report.Section h6 - evaluation codes.Section h11 - manufacturer narrative.The anchor was not returned to saluda.A root cause for the migration could not be definitively determined, but likely a result of a motor vehicle accident.Review of x-rays provided could not confirm the reported migration due to lack of original lead location as reference.The evoke scs system surgical guide states "the risks associated with the implantation and use of a spinal cord stimulation system include lead migration from the location chosen at initial implantation, resulting in stimulation changes.The patient may require surgery (including revision, explant, and replacement) as a result.".

• Brand Name: EVOKE ACTIVE ANCHOR KIT (US)
• Common Device Name: SCS ANCHOR
• 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: 23846000
• Report Number: 3021836309-2025-00388
• Device Sequence Number: 9959077
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• 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: 2024
• 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,Followup
• Report Date (Section B): 03/20/2026

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: 07/16/2025
• Device Model Number: 102996
• Device Catalogue Number: 3043
• Device Lot Number: 9015897638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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