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

Model Number	102880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pneumothorax (2012); Tachycardia (2095); Discomfort (2330); Sleep Dysfunction (2517); Tics/Tremor (4425); Eye Pain (4467); Photophobia (4801); Diplopia/Double Vision (4802)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Following implantation of the trial evoke spinal cord stimulation (scs) system, the patient reported right-sided ocular discomfort, watering of the eye, and photophobia.Narcotics were prescribed; however, the indication for narcotic use remains unknown (i.E., whether prescribed for these symptoms or pre-existing pain).The scs system was turned off and removed the next day.The patient reported that device removal was painful and presented to the emergency department later that day.Imaging demonstrated pneumothorax and air within the spinal canal; no intervention was reported.The patient was evaluated by an ophthalmologist on (b)(6) 2026, who ruled out primary ocular causes for the symptoms and referred the patient to a neuro-ophthalmologist.Between (b)(6) 2026, the patient developed severe eye pain, photophobia, diplopia, insomnia, tachycardia, tremors, and ptsd-like night terrors.On (b)(6) 2026, the patient was transported to the hospital with suspected stroke which was later ruled out.The patient was hospitalized and a diagnostic mri was performed.The patient was discharged with a recommendation for neuro-ophthalmology follow up.At the time of reporting, additional information is not available.
Additional Manufacturer Narrative
The leads were not returned to saluda.Device logs were reviewed and identified intermittent disconnected electrodes.The impedance findings are not considered to be related to the patient's reported symptoms.A root cause for the reported patient symptoms could not be definitively determined.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "epidural hemorrhage, spinal cord injury, possible paralysis or other neurological complications" and "weakness, clumsiness, numbness, abnormal sensations or pain." the manufacturing records were reviewed and product met all requirements for release.Lead information: serial/lot #: (b)(6), manufacture date: aug 6, 2024, expiration date: aug 6, 2026.Serial/lot #: (b)(6), manufacture date: nov 8, 2024, expiration date: nov 8, 2026.

• Brand Name: EVOKE CAP12 TRIAL 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: 25576254
• Report Number: 3021836309-2026-00192
• Device Sequence Number: 21087667
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 06/22/2026

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: 08/06/2026
• Device Model Number: 102880
• Device Catalogue Number: 3016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 08/06/2024
• 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; Hospitalization
• Patient Sex: Unknown