MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US); SCS LEAD

Model Number	102879
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The leads were discarded.An impedance log review confirmed high impedance on electrode e7 and disconnected electrode on e8.A single x-ray image was provided which was unable to confirm the reported lead migration.Without device return, it is not possible to reach a definitive root cause.The evoke scs system clinical manual details impedance as, "an electrode with a cross through it has high impedance (4000 o) and may be disconnected.A disconnected electrode shows an impedance of 8 and cannot be used for stimulation." in addition, the evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "undesirable changes in stimulation sensation and/or location.Lead migration or suboptimal placement, which may result in undesirable stimulation changes." and continues by stating, "the patient may require surgery (including revision, explant, and replacement)" as a result of these risks.Both leads used were from the same lot.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported inadequate pain relief.X-ray imaging identified a lead migration.An impedance check was performed to identify high impedance.A lead revision procedure was completed to resolve the reported event and restore therapy.

• Brand Name: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (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: 22509989
• Report Number: 3021836309-2025-00192
• Device Sequence Number: 21016879
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/15/2025

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: 05/10/2025
• Device Model Number: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9015573947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 05/11/2023
• 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: Female