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

Model Number	EVOKE ACTIVE ANCHOR KIT (US)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported experiencing pain at the region of the anchor used with the scs lead.During the revision procedure, the leads could not be fully re-inserted into the closed loop stimulator (cls) so the scs system was replaced.
Additional Manufacturer Narrative
The original anchors were not returned for analysis.Temporary or persistent post-surgical pain at hardware implantation sites requiring surgery (including revision, explant, and replacement) as a result is listed as a potential risk in the manufacturer's instructions for use (ifu).The cls and leads were also returned for analysis which could not confirm the cause of the difficulty inserting the leads into the cls during the procedure.The manufacturing records were reviewed.Product met all requirements for release with no anomalies identified.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS ANCHOR
• 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: 18288646
• Report Number: 3021836309-2023-00163
• Device Sequence Number: 12436592
• Product Code: LGW
• UDI-Device Identifier: 09352307000810
• UDI-Public: 09352307000810
• 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
• 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): 12/07/2023

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: 12/08/2024
• Device Model Number: EVOKE ACTIVE ANCHOR KIT (US)
• Device Catalogue Number: 3043
• 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: 11/15/2023
• Initial Report FDA Received Date: 12/07/2023
• Date Device Manufactured: 12/09/2022
• 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