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
The evoke scs system was not returned to saluda.X-ray images provided to saluda were reviewed and confirmed migration of the leads and the cls.The cls migration may have attributed to the reported difficulty charging the cls.The root cause of the lead and cls migration could not be definitively determined; however, the patient¿s previous fall may have contributed to the reported event.The evoke scs system surgical guide details proper cls anchoring including, "ensure that the cls lays parallel to the skin surface so that charging is not compromised.Secure the cls to the subcutaneous fascia with sutures through the holes in the header of the cls.¿ the evoke scs system surgical guide continues with detailing potential risks associated with surgery and spinal cord stimulation including, "lead migration or suboptimal placement, which may result in undesirable stimulation changes, and the patient may require surgery (including revision, explant, and replacement) as a result¿.Cls information: brand name: evoke closed loop stimulator (cls) (us) model: 102901 catalog: 3042 serial number: (b)(6) udi: (b)(4) 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 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: 50084976
• Report Number: 3021836309-2026-00228
• Device Sequence Number: 10479752
• 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: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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: Male