MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	101345
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lead was not returned to saluda for analysis.The root cause of the reported event cannot be definitively determined due to insufficient information.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "breakage of the lead, or malfunction or failure of other system components, which may result in undesirable changes or loss of stimulation and the patient may require surgery (including revision, explant, and replacement) as a result.¿ the medwatch report was provided without information for section a and section e.Device details were not provided, d1 - evoke 12c percutaneous lead kit - 60cm (us) and d4 ¿ 101345 have been used as placeholders.Required fields may be unpopulated because the information is unavailable and additional information cannot be obtained as the initial reporter elected not to be identified.
Event or Problem Description
It was reported in medwatch: mw5177282, that a patient implanted with an evoke spinal cord stimulation (scs) system underwent a revision procedure during which the saluda lead was removed because it was assessed as defective.

• Brand Name: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM (US)
• Common Device Name: SCS LEAD
• 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: 23630357
• Report Number: 3021836309-2025-00342
• Device Sequence Number: 9290630
• Product Code: LGW
• UDI-Device Identifier: 09352307000087
• UDI-Public: 09352307000087
• Combination Product (Y/N): N
• 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: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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 Model Number: 101345
• Device Catalogue Number: 3008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/24/2025
• 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