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

Model Number	102996
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with an evoke spinal cord stimulation (scs) system was evaluated for a change in stimulation.A lead migration was confirmed.The patient reported a fall prior to the reported event.The evoke scs system did not cause or contribute to the patient¿s falls.A lead revision was completed and therapy restored.
Additional Manufacturer Narrative
The device remains in use.Without the return of the device, it is not possible to reach a definitive root cause.The reported event mentions the patient¿s prior falls, which likely contributed to lead migration event.The evoke scs system surgical guide details risks associated with surgery and spinal cord stimulation, "lead migration or suboptimal placement, which may result in undesirable stimulation changes" and continues to by stating, "the patient may require surgery (including revision, explant, and replacement)" as a result of these risks.

• 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 ; AU 2113
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; - ; AU -
• Manufacturer Contact: sadie mauser ; 5 eden park drive; AU -
• MDR Report Key: 21469447
• Report Number: 3021836309-2025-00042
• Device Sequence Number: 19746033
• Product Code: LGW
• UDI-Device Identifier: 09352307001718
• UDI-Public: 09352307001718
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/26/2025

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: 102996
• Device Catalogue Number: 3043
• Device Lot Number: 9014702810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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