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	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient previously implanted with an evoke spinal cord stimulation (scs) system reported decrease in pain relief and unintended stimulation.The patient reported that they had been involved in physical activities, including lifting heavy objects.An x-ray was obtained which revealed migration of the right lead.A revision was performed and the evoke scs system was replaced.Therapy has been restored following the revision procedure.
Additional Manufacturer Narrative
The devices were discarded and are unavailable for analysis.A review of the x-ray confirmed lead migration.The reported changes in stimulation may be caused by the lead migration.The cause of lead migration could not be determined.The evoke scs system surgical guide states the following ¿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 may require surgery (including revision, explant, and replacement) as a result.¿.

• 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: 20584906
• Report Number: 3021836309-2024-00050
• Device Sequence Number: 8827747
• 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
• Report Date (Section B): 11/01/2024

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: 10/09/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown