MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	102878
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
While traveling abroad, a patient implanted with an evoke spinal cord stimulation (scs) system was evaluated in the emergency department for a possible infection at the evoke cap12 percutaneous lead implant site.Additional details regarding the event were not provided to the saluda representative.
Additional Manufacturer Narrative
The patient was evaluated by physician (b)(6).Investigation of this event is in progress.Once the investigation has been completed, a supplemental report will be submitted.
Event or Problem Description
The patient returned from international travel and met with a saluda representative on 27 march 2026.The patient reported that, during their visit to the emergency department, an explant procedure was performed and antibiotics were administered.The patient is expected to continue receiving monthly intravenous antibiotics treatment.
Additional Manufacturer Narrative
The evoke scs system was not returned to saluda.The root cause of the infection cannot be definitively determined.The evoke scs system surgical guide states, ¿the risks associated with the implantation and use of a spinal cord stimulation system, include ¿infection that may require hospitalization with intravenous antibiotic therapy and the patient may require surgery (including revision, explant, and replacement) as a result.¿ the manufacturing records were reviewed and the product met all requirements for release.

• Brand Name: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)
• Common Device Name: SCS LEAD
• 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, ns - ; AU -
• MDR Report Key: 24454433
• Report Number: 3021836309-2026-00054
• Device Sequence Number: 10148546
• Product Code: LGW
• UDI-Device Identifier: 09352307001640
• UDI-Public: 09352307001640
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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 Model Number: 102878
• Device Catalogue Number: 3008
• Device Lot Number: 9018216317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2024
• 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: Female