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

Model Number	EVOKE CLOSED LOOP STIMULATOR (CLS)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted evoke spinal cord stimulation (scs) system was discarded by the hospital.The cause of the infection could not be determined, scs system was explanted to resolve the infection.Infection that may require hospitalization with intravenous antibiotic therapy and surgery (including revision, explant, and replacement) is listed as a potential risk in the manufacturer's instruction for use (ifu).The manufacturing records were reviewed.Product met all requirements for release with no anomalies identified.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported experiencing a fever and fluid discharge from their incision site.The patient was prescribed antibiotics to resolve the reported symptoms which was unsuccessful.The scs system was explanted.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS IPG
• 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: 19268671
• Report Number: 3021836309-2024-00239
• Device Sequence Number: 17999630
• Product Code: LGW
• UDI-Device Identifier: 09352307000292
• UDI-Public: 09352307000292
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/08/2024

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: 07/11/2025
• Device Model Number: EVOKE CLOSED LOOP STIMULATOR (CLS)
• Device Catalogue Number: 3002
• 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: 04/10/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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