MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS LEAD

Model Number	EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The leads remain implanted within the patient.The root cause of the epidural puncture could not be determined.Cerebrospinal fluid (csf) leakage with possible fistula formation, is listed as a potential risk in the evoke scs system surgical guide.The manufacturing records were reviewed, and the product met all requirements for release with no anomalies identified.Manufacturing and expiry dates of the leads: (b)(6) - mfg date: 7-aug-2023, exp date: 6-aug-2025.(b)(6) - mfg date: 12-sep-2023, exp date: 11-sep-2025.
Event or Problem Description
During the implant procedure for an evoke spinal cord stimulation (scs) system, an epidural puncture occurred while implanting the leads.An epidural blood patch procedure was performed.The patient reported experiencing pain in their right leg post procedure.It had been reported that the patient has been recovering well.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 19955516
• Report Number: 3021836309-2024-00294
• Device Sequence Number: 21040767
• Product Code: LGW
• UDI-Device Identifier: 09352307000773
• UDI-Public: 09352307000773
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/09/2024

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: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
• Device Catalogue Number: 3008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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