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

Model Number	EVOKE ACTIVE ANCHOR KIT
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted evoke active anchor and lead were discarded and not available for analysis.Without the return of the anchor, it is not possible to reach a definitive root cause of the lead migration.Lead migration which may result in undesirable stimulation changes and requiring surgery (including revision, explant, and replacement) as a result is listed as a potential risk in manufacturer's instructions for use.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 pain and a motor response.The evoke scs system and a physician exam confirmed the pain was due to lead migration causing unintended stimulation.A lead revision was performed three days later.Post procedure, the patient was reported to be receiving adequate therapy.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS ACTIVE 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: 18899757
• Report Number: 3021836309-2024-00208
• Device Sequence Number: 7887184
• Product Code: LGW
• UDI-Device Identifier: 09352307000810
• UDI-Public: 09352307000810
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/13/2024

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: 01/25/2025
• Device Model Number: EVOKE ACTIVE ANCHOR KIT
• Device Catalogue Number: 3043
• Device Lot Number: 9015897638
• 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: 02/14/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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