MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD DIRECT CLAMP ACTIVE ANCHOR KIT; SCS DIRECT CLAMP ACTIVE ANCHOR

Model Number	104523
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/04/2026
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 change in stimulation.X-ray was performed and a lead migration was identified.Reprogramming was unable to restore adequate therapy.A lead revision was completed to resolve the issue.
Additional Manufacturer Narrative
Additional information: section d4 - expiration date.Section g3 - date received by manufacturer.Section g6 - type of report.Section h4 - device manufacture date.Section h6 - evaluation codes.Section h11 - manufacturer narrative.The anchor was not returned to saluda.A 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 result.".

• Brand Name: DIRECT CLAMP ACTIVE ANCHOR KIT
• Common Device Name: SCS DIRECT CLAMP ACTIVE 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: 24740926
• Report Number: 3021836309-2026-00101
• Device Sequence Number: 12217530
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 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,Followup
• Report Date (Section B): 05/15/2026

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: 104523
• Device Catalogue Number: 3043
• Device Lot Number: 9017991808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2024
• 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