MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CLOSED LOOP STIMULATOR (CLS); SCS IPG

Model Number	101144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted evoke scs system was discarded.The cause of the infection could not be established.The evoke scs system surgical guide includes the following: infection that may require hospitalization with intravenous antibiotic therapy and may require surgery (including revision, explant, and replacement) as a result.The manufacturing records were reviewed, and the product met all requirements for release with no anomalies identified.
Event or Problem Description
A patient previously implanted with an evoke spinal cord stimulation (scs) system was evaluated for an infection at the implantation site of their evoke closed loop stimulator (cls).The evoke scs system was explanted.The patient was reported to be recovering well following the explant procedure.

• Brand Name: EVOKE CLOSED LOOP STIMULATOR (CLS)
• Common Device Name: SCS IPG
• 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: 20436467
• Report Number: 3021836309-2024-00028
• Device Sequence Number: 8166021
• Product Code: LGW
• UDI-Device Identifier: 09352307000292
• UDI-Public: 09352307000292
• Combination Product (Y/N): N
• 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): 10/14/2024

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: 06/08/2025
• Device Model Number: 101144
• Device Catalogue Number: 3002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2023
• 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