MAUDE Adverse Event Report: Saluda Medical Pty Ltd Direct Clamp Active Anchor Kit; SCS Anchor

Model Number	104523
Medical Device Problem Codes	Failure to Charge (1085); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported difficulty charging their evoke closed loop stimulator (cls).The patient reported a previous fall; the evoke scs system didn¿t cause or contribute to the patient¿s fall.X-ray imaging identified migration of two (2) leads and the cls was in an angled position.The physician elected to perform a revision procedure to replace the migrated leads and reposition the cls.During the revision procedure, the physician encountered scar tissue and could not regain posterior access to place the new leads.As a result, the revision procedure was aborted, the patient subsequently underwent explantation of the evoke scs system.
Additional Manufacturer Narrative
Cls information: brand name: evoke closed loop stimulator (cls) (us) model: 102901 catalog: 3042 serial number: (b)(6) udi: 09352307001572 expiration date: 21september2026.

• Brand Name: Direct Clamp Active Anchor Kit
• Common Device Name: SCS Anchor
• Manufacturer (Section D): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw - ; AU -
• 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: 50084974
• Report Number: 3016111136-2026-00154
• Device Sequence Number: 10479751
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026
• Report Date (Section F): 07/30/2026

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: 09/12/2026
• Device Model Number: 104523
• Device Catalogue Number: 3043
• Device Lot Number: 9017991808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male