MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US); SCS LEAD

Model Number	102879
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation has been completed, a supplemental report will be submitted.Second lead information: brand name: evoke cap12 percutaneous lead kit - 90cm, model: 102879, catalog: 3009, lot/batch number: 9014926319, udi: (b)(4), the anchor is a component of the reported lead kit.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported a change in stimulation.The patient had reported adequate pain relief previously.An x-ray and impedance check were performed with no device issues identified.The patient reported previous falls; the evoke scs didn¿t cause or contribute to the patient¿s falls.The physician assessed that the patient¿s falls may have damaged the evoke closed loop stimulator (cls) and contributed to the changes in stimulation.A revision procedure (reported under manufacturer report number - 3021836309-2025-00161) was performed to remove the evoke cls and connect the leads to an evoke external closed loop stimulator (ecls).The stimulation change was not resolved following the revision procedure.Further troubleshooting performed, with patient leads connected to the evoke external closed loop stimulator (ecls), identified lead migration contributing to the reported event.An explant procedure was performed to resolve the reported event.
Additional Manufacturer Narrative
Additional information: section d - expiration date.Section g - date received by manufacturer; type of report.Section h - device manufacture date; evaluation codes.The evoke scs system was not returned to saluda for analysis.The root cause of the lead migration 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 lead migration or suboptimal placement, which may result in undesirable stimulation changes and the patient may require surgery (including revision, explant, and replacement) as a result".Second lead information: manufacture date: 01/12/2023, expiration date: 01/11/2025.

• Brand Name: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (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, nsw - ; AU -
• MDR Report Key: 22298582
• Report Number: 3021836309-2025-00162
• Device Sequence Number: 18283398
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: 04/03/2026
• Device Model Number: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9017195906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2024
• 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: Unknown