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	Cerebrospinal Fluid Leakage (1772); Headache (1880); Nausea (1970); Neck Pain (2433)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the trial period of the evoke spinal cord stimulation (scs) system, the patient presented to the emergency department with headache, nausea, and neck pain.The trial leads were removed.Magnetic resonance imaging (mri) identified a cerebrospinal fluid (csf) leak.A blood patch procedure was performed.At the time of reporting, the patient's symptoms were reported to be resolving.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: section d4 - expiration date.Section g3 - date received by manufacturer.Section g6 - type of report.Section h4 - device manufacture date.Section h6 - evaluation codes.Section h11 - manufacturer narrative.The lead was not returned to saluda.A device log review identified an intermittent shorted electrode.The root cause of the cerebrospinal fluid leak and shorted electrode could not be definitively determined.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "cerebrospinal fluid (csf) leakage with possible fistula formation" and "abnormal sensations or pain." the evoke scs system clinical manual details impedance, "electrodes with a lightning bolt through them may be shorted (< 50 o) and care should be taken when programming." the manufacturing records were reviewed and product met all requirements for release.

• 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: 25056289
• Report Number: 3021836309-2026-00139
• Device Sequence Number: 13118447
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• 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: 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,Followup
• Report Date (Section B): 05/27/2026

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: 102880
• Device Catalogue Number: 3016
• Device Lot Number: 9018317993
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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