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

Model Number	EVOKE CLOSED LOOP STIMULATOR (CLS)
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Implant Pain (4561)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No devices were returned to saluda for analysis.Without a returned device, it is not possible to reach a definitive root cause for the reported change in therapy and pain at the implant site.For the change in therapy, x-rays were provided which confirm the migration.Per the manufacturer's instructions for use (ifu) "lead migration from the location chosen at initial implantation resulting in stimulation change.Note: you may require surgery (including revision, explant and/or replacement) as a result of any of the above." for the reported pain at implant site, the evoke scs system surgical guide states the following: "the risks associated with the implantation and use of a spinal cord stimulation system include: persistent post-surgical pain at hardware implantation sites.The patient may require surgery (including revision, explant, and replacement) as a result of any of the above." per the event report, a revision procedure was completed to resolve the issues.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for a change in stimulation and pain at the closed loop stimulator (cls) implant site.An x-ray was obtained which revealed a lead migration.A revision was performed to reposition the cls and replace the migrated lead.Therapy has been restored following the revision procedure.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS IPG
• 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: 20532794
• Report Number: 3021836309-2024-00042
• Device Sequence Number: 7817678
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: 08/17/2022
• Device Model Number: EVOKE CLOSED LOOP STIMULATOR (CLS)
• Device Catalogue Number: 1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 09/21/2021
• 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