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

Model Number	EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and is not available for return to saluda for analysis.The root cause of the implantation site not closing is not able to be definitively 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: cls migration or suboptimal placement, which may result in pain or difficulty in charging.Skin irritation.The patient may require surgery (including revision, explant, and replacement) as a result of any of the above." a revision was performed to resolve the reported event.
Event or Problem Description
A patient previously implanted with an evoke spinal cord stimulation (scs) system was evaluated for their implantation site not closing as expected.The physician attributed this to the suturing technique.A revision was performed and the patient therapy restored.

• 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: 20429417
• Report Number: 3021836309-2024-00027
• Device Sequence Number: 15575288
• Product Code: LGW
• UDI-Device Identifier: 09352307000292
• UDI-Public: 09352307000292
• 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: 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): 10/11/2024

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: 04/12/2024
• Device Model Number: EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
• Device Catalogue Number: 3042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/11/2024
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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