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 device model implanted.The reason for the device replacement was not disclosed to saluda.
Additional Manufacturer Narrative
The anchor was returned for analysis and did not pass functional testing.Examination of the anchor under magnification identified a buildup of material in the threaded bore at the base of the clamp, which was not able to be removed during the decontamination process.It is possible that the material in the clamp mechanism could have an impact on the retention force of the anchors but this could not be definitively determined through the testing performed.The evoke scs system surgical guide lists lead migration from the location chosen at initial implantation, requiring surgery (including revision, explant, and replacement) as a result as a potential risk associated with the implantation and use of a spinal cord stimulation system.

• 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
• 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: 20846677
• Report Number: 3021836309-2024-00309
• Device Sequence Number: 3759650
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: COMPLAINTS@S
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/04/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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