MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD

Model Number	102880
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Migration (4003)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Incontinence (1928); Muscle Weakness/Atrophy (1967); Pain (1994); Syncope/Fainting (4411)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device used - 2nd implanted lead: product description: evoke cap12 trial percutaneous lead kit - 60cm model # : 102880 catalog#: 3016 serial/lot #: (b)(6) manufacture date: 12jun2024 expiration date: 12jun2026 implant date: (b)(6) 2025 explant date: (b)(6) 2025.
Event or Problem Description
During the trial period of an evoke spinal cord stimulation (scs) system,the patient was evaluated for loss of stimulation and bleeding at the lead implant site.The dressings were changed and the implanting physician administered localised steroid injections.An x-ray was obtained and confirmed lead migration.The patient¿s trial leads were removed the following day.Six (6) days after removal of the evoke scs trial leads, the patient was evaluated in a hospital setting for loss of consciousness, incontinence and lower limb weakness.The patient was subsequently discharged with all symptoms resolved except residual lower limb weakness.The patient is undergoing physical therapy to resolve the persisting symptom.It was confirmed that these symptoms were not present during the evoke scs system trial period and that all trial evoke scs system devices were explanted when these symptoms began.The implanting physician has not provided an assessment of the symptoms which onset following the evoke scs system trial period.

• Brand Name: EVOKE CAP12 TRIAL 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
• MDR Report Key: 22911361
• Report Number: 3016111136-2025-00139
• Device Sequence Number: 9055048
• Product Code: LGW
• UDI-Device Identifier: 09352307000797
• UDI-Public: 09352307000797
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025
• Report Date (Section F): 08/05/2025

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: 01/10/2026
• Device Model Number: 102880
• Device Catalogue Number: 3016
• Device Lot Number: 9016773735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 01/11/2024
• 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