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

Model Number	102996
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for lead migration.An x-ray was obtained and confirmed migration of both leads.A revision procedure was completed to resolve the issue and restore therapy.
Additional Manufacturer Narrative
Additional information: section d9 device available for evaluation, device returned to manufacturer and date returned to manufacturer section g date received by manufacturer and type of report section h device evaluated by manufacturer and evaluation codes the devices were returned to saluda for analysis.The returned anchors were noted to have tissue around and within the devices which was not able to be fully removed.Visual inspection of the anchor, including clamp and set screw, were completed with some limitation due to the condition of the returned anchors.Both anchors failed functional retention testing, confirming the reported migration event.The evoke scs system surgical guide states, ¿the risks associated with the implantation and use of a spinal cord stimulation system include 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.¿.

• Brand Name: EVOKE ACTIVE ANCHOR KIT (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: 21175620
• Report Number: 3021836309-2025-00016
• Device Sequence Number: 14518669
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/19/2025

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: 02/27/2025
• Device Model Number: 102996
• Device Catalogue Number: 3043
• Device Lot Number: 9015193727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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