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

Model Number	104523
Medical Device Problem Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lead information: product description: evoke cap12 percutaneous lead kit - 90cm model # : 102879 catalog#: 3009 serial/lot #: (b)(6).
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system underwent an impedance check during the initial programming visit, and disconnected electrode and high impedances were identified.An x-ray revealed a lead migration.The patient reported difficulty adhering to post-procedural restrictions.A revision procedure was performed, during which the lead and anchor were replaced.

• Brand Name: DIRECT CLAMP ACTIVE ANCHOR KIT
• Common Device Name: SCS DIRECT ACTIVE ANCHOR
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• MDR Report Key: 25681496
• Report Number: 3016111136-2026-00136
• Device Sequence Number: 18572344
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2026
• Report Date (Section F): 06/05/2026

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: 9018360908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2026
• 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