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

Model Number	104462
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evoke scs system was not returned to saluda.The x-rays provided confirmed lead migration.The root cause of lead migration could not be definitively determined, but the patient's fall or manipulation of the cls may have contributed to lead migration, resulting in stimulation changes.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 a result.¿.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for inadequate pain relief following multiple falls unrelated to the evoke scs system.An x-ray confirmed lead migration and the patient was subsequently reprogrammed in an open-loop program.It was additionally reported that the patient manipulated the implanted evoke closed loop stimulator (cls) causing the device to rotate within the pocket and further dislodged the leads.A revision procedure was performed, during which the evoke scs system was replaced.

• Brand Name: ACTIVE ANCHOR KIT L (US)
• Common Device Name: SCS 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: 24557862
• Report Number: 3021836309-2026-00068
• Device Sequence Number: 18350093
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 03/10/2026

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: 02/11/2026
• Initial Report FDA Received Date: 03/10/2026
• 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