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	Pain (1994)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The trial evoke spinal cord stimulation (scs) system was not returned to saluda.The cause of the reported patient symptom could not be established.Weakness, clumsiness, numbness, abnormal sensations or pain requiring surgery (including revision, explant, and replacement) as a result, is listed as a potential risk in manufacturer¿s instructions for use (ifu).The manufacturing records, including sterilization records, were reviewed and the product met requirements for release.Section d4 for lead lot number 9015326068.Expiration date ¿ 20 march 2025.Unique identifier (udi) - (b)(4).Section h4 device manufacture date ¿ 21 march 2023.
Event or Problem Description
A patient reported experiencing post-surgery pain following implant of evoke spinal cord stimulation (scs) trial system.The patient¿s scs system was explanted prior to any programming.

• 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: 19644996
• Report Number: 3021836309-2024-00268
• Device Sequence Number: 15335182
• Product Code: LGW
• UDI-Device Identifier: 09352307000773
• UDI-Public: 09352307000773
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 07/01/2024

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 Expiration Date: 04/20/2025
• Device Model Number: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
• Device Catalogue Number: 3008
• Device Lot Number: 9015475915
• 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: 05/30/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• 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: Unknown