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

Model Number	102996
Medical Device Problem Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evoke scs system was discarded.An image of device logs was provided which confirmed disconnected electrodes.X-rays provided confirmed lead migration.The lead migration likely contributed to the disconnected electrodes.The root cause of the lead migration cannot 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 the patient may require surgery (including revision, explant, and replacement) as a result.¿ the evoke scs system mri guidelines provide the following details, "mri compatibility has not been determined for a system where the impedance of the lead shows disconnected or shorted channels.Impedance measurement must be performed to ensure no channels are disconnected or shorted prior to scanning.".
Event or Problem Description
When performing the evoke spinal cord stimulation (scs) system device check before magnetic resonance imaging (mri), disconnected electrodes were identified on the right lead.X-ray confirmed migration of right lead.A revision procedure was performed, and the physician elected to replace the evoke scs system and restore mri compatibility.

• 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: 23435281
• Report Number: 3021836309-2025-00326
• Device Sequence Number: 12895093
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 10/31/2025

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: 03/29/2025
• Device Model Number: 102996
• Device Catalogue Number: 3043
• Device Lot Number: 9015363039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 03/30/2023
• 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: Male