MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EPI MED NEEDLE 6.5". EPI MED PN 107-1614; SCS NEEDLE

Model Number	104497
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/09/2025
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.
Event or Problem Description
During a trial implant procedure for the evoke spinal cord stimulation (scs) system, the patient experienced a cerebrospinal fluid (csf) leak and the physician elected to abort the procedure.Following day, the patient was evaluated at the emergency department and a blood patch procedure was completed.The patient was discharged three (3) days later with all symptoms resolved.
Additional Manufacturer Narrative
Additional information: section d4 - expiration date, unique identifier (udi) #, section g3 - date received by manufacturer, section g6 - type of report, section h4 - device manufacture date, section h6 - evaluation codes, section h10 - manufacturer narrative.The needle was discarded.The cause of the cerebrospinal fluid leak cannot be definitively determined.Evoke scs system surgical guide lists cerebrospinal fluid (csf) leakage, requiring surgery as a result as a potential risk associated with the implantation and use of a spinal cord stimulation system.The manufacturing records were reviewed, and the product met all requirements for release with no anomalies identified.

• Brand Name: EPI MED NEEDLE 6.5". EPI MED PN 107-1614
• Common Device Name: SCS NEEDLE
• 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: 23277405
• Report Number: 3021836309-2025-00304
• Device Sequence Number: 12975324
• Product Code: LGW
• UDI-Device Identifier: 10818788020373
• UDI-Public: 10818788020373
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/31/2025

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 Model Number: 104497
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• 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: Hospitalization; Other
• Patient Sex: Female