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

Model Number	102878
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.Both leads were from the same lot.Cls information: product description: evoke closed loop stimulator (cls), model # : 101144, catalog#: 3002, serial/lot #: (b)(6).
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for inadequate pain relief and noted that the evoke closed loop stimulator (cls) felt warm during charging.Reprogramming was attempted but could not restore adequate therapy.Lead migration was confirmed via x-ray imaging.A revision procedure was performed and the evoke scs system was replaced.
Additional Manufacturer Narrative
The evoke scs system was not returned to saluda.Review of device logs identified no charging related overheating errors and confirmed a disconnected electrode.The root cause of the disconnected electrode and lead migration was unable to be definitively determined.The root cause of the cls temperature issue was unable to be definitively determined.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "lead migration or suboptimal placement, which may result in undesirable stimulation changes, and the patient may require surgery (including revision, explant, and replacement)".The evoke scs system user manual includes the following warning, "the charger, charger coil and/or cls may become hot during charging.".

• 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, nsw - ; AU -
• MDR Report Key: 24380081
• Report Number: 3021836309-2026-00035
• Device Sequence Number: 10519019
• Product Code: LGW
• UDI-Device Identifier: 09352307001640
• UDI-Public: 09352307001640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• 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): 03/23/2026

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 Expiration Date: 02/06/2025
• Device Model Number: 102878
• Device Catalogue Number: 3008
• Device Lot Number: 9015081754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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: Male