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	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Saluda representatives were notified of inadequate pain relief and lead migration for a patient implanted with an evoke spinal cord stimulation (scs) system.An explant was reported to be completed to resolve the reported event.Saluda representatives were initially notified of this event through a 3rd party and no further information has been received.The explant date was not confirmed and the exact date of explant unknown.(b)(6) 2025 is selected as an approximate event date.
Additional Manufacturer Narrative
The evoke active anchor was not returned for analysis.It was confirmed that lead migration was identified through imaging; no imaging was provided for review.The root cause of the reported event is unable to be definitively determined.The evoke scs system surgical guide states, ¿the risks associated with the implantation and use of a spinal cord stimulation system include lead migration, which may result in undesirable stimulation changes, and 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: 22936357
• Report Number: 3021836309-2025-00245
• Device Sequence Number: 9878622
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/02/2025

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: 02/05/2026
• Device Model Number: 102996
• Device Catalogue Number: 3043
• Device Lot Number: 9016910305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 02/06/2024
• 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