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

Model Number	EVOKE CLOSED LOOP STIMULATOR (CLS)
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported experiencing difficulties using the external components, evoke patient controller (epc) and evoke charger kit.It was reported that for the epc and the charger to connect, the patient had to place the device behind their back, which was straining their shoulder.It was reported that a separate planned procedure was expected to resolve their pain and therefore the patient's scs system was explanted.
Additional Manufacturer Narrative
The explanted evoke closed loop stimulator (cls), leads, and active anchors were returned to saluda for analysis.The cls passed functional testing.A reference charger and evoke patient controller (epc) were connected successfully with the returned cls, and the reported difficulty could not be replicated.A saluda representative had confirmed that the external components were functioning as expected when checked during multiple follow-up visits.Log reviews indicated some instances of charging sessions in a short period of time, which appear consistent with the patient losing connection between the two devices resulting in an ended charging session.The manufacturing records were reviewed, and the product met all requirements for release with no anomalies identified.

• 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; AS 2113
• MDR Report Key: 19473413
• Report Number: 3021836309-2024-00254
• Device Sequence Number: 20561201
• Product Code: LGW
• UDI-Device Identifier: 09352307000292
• UDI-Public: 09352307000292
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/05/2024

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: 04/04/2025
• Device Model Number: EVOKE CLOSED LOOP STIMULATOR (CLS)
• Device Catalogue Number: 3002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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