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

Model Number	102996
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient previously implanted with an evoke spinal cord stimulation (scs) system was evaluated for stimulation at the closed loop stimulator (cls) implant site receiving therapy.An x-ray was obtained which confirmed lead migration to the cls implant site.A revision procedure was completed to resolve the reported event.
Additional Manufacturer Narrative
Additional devices used: evoke cap12 percutaneous lead kit - 60cm model - 102878, catalog - 3008, lot number - 9016208764.Evoke cap12 percutaneous lead kit - 60cm model - 102878, catalog - 3008, lot number - 9016245043.The devices were discarded.The provided x-ray confirms the lead migration.The root cause of the migration event is not able to be definitively determined.The evoke scs system surgical guide lists potential risks associated with surgery and spinal cord stimulation including, "lead migration or suboptimal placement, which may result in undesirable stimulation changes" and "undesirable changes in stimulation sensation and/or location".The surgical guide continues by stating, "the patient may require surgery (including revision, explant, and replacement)" as result of these risks.¿.

• Brand Name: EVOKE ACTIVE ANCHOR KIT
• 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: 21689990
• Report Number: 3021836309-2025-00071
• Device Sequence Number: 21045223
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/25/2025

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 Expiration Date: 01/01/2026
• Device Model Number: 102996
• Device Catalogue Number: 3043
• Device Lot Number: 9016723709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 01/02/2024
• 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: Female