MAUDE Adverse Event Report: Saluda Medical PTY LTD Direct Clamp Active Anchor Kit; SCS Anchor

Model Number	104523
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for possible lead migration.The patient also reported discomfort at the evoke closed loop stimulator (cls) implant site due to contact with the patient¿s belt.X-ray imaging confirmed migration of both evoke leads.During the revision procedure, the physician noted that the anchors were functioning as intended and the patient¿s post-implant activity level may have contributed to the lead migration.One lead was replaced, the other lead was repositioned, the existing anchors were reused, the cls was repositioned to a higher location.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: Direct Clamp Active Anchor Kit
• Common Device Name: SCS Anchor
• Manufacturer (Section D): Saluda Medical PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50754796
• Report Number: 3016111136-2026-00190
• Device Sequence Number: 9361610
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026
• Report Date (Section F): 09/14/2026

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: 9018427705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown