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

Model Number	104462
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation has been completed, a supplemental report will be submitted.H3 other text: device not returned to manufacturer.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for inadequate pain relief.An x-ray identified lead migration.A revision procedure was performed, during which anchors and a lead were replaced, and one lead was repositioned.
Additional Manufacturer Narrative
Additional information: section d - expiration date; udi.Section g - date received by manufacturer; type of report.Section h - device manufacture date; evaluation codes.The devices were not returned to saluda.The root cause of the lead migration could not 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 from the location chosen at initial implantation, resulting in stimulation changes and the patient may require surgery (including revision, explant, and replacement) as a result of any of the above.".

• Brand Name: ACTIVE ANCHOR KIT L (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: 24885361
• Report Number: 3021836309-2026-00115
• Device Sequence Number: 9851947
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/13/2026

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: 104462
• Device Catalogue Number: 3043
• Device Lot Number: 9018672046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2025
• 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: Female