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

Model Number	EVOKE ACTIVE ANCHOR KIT (US)
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Unintended Movement (3026)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During routine programming, a patient previously implanted with an evoke spinal cord stimulation (scs) system reported stimulation in their right upper extremity.An x-ray was obtained and confirmed a lead migration.A lead revision was completed to resolve the issue and restore therapy.It was additionally reported that the patient¿s closed loop stimulator (cls) was replaced and a newer model implanted.The reason for the device replacement was not disclosed to saluda.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS ANCHOR
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• MDR Report Key: 20845816
• Report Number: 3016111136-2024-00032
• Device Sequence Number: 8255962
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024
• Report Date (Section F): 11/04/2024

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: 12/08/2024
• Device Model Number: EVOKE ACTIVE ANCHOR KIT (US)
• Device Catalogue Number: 3043
• Device Lot Number: 9014702810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female