MAUDE Adverse Event Report: Saluda Medical PTY LTD Direct Clamp Active Anchor Kit; SCS Anchor

Model Number	104523
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for possible lead migration.The patient also reported discomfort at the evoke closed loop stimulator (cls) implant site due to contact with the patient¿s belt.X-ray imaging confirmed migration of both evoke leads.During the revision procedure, the physician noted that the anchors were functioning as intended and the patient¿s post-implant activity level may have contributed to the lead migration.One lead was replaced, the other lead was repositioned, the existing anchors were reused, the cls was repositioned to a higher location.
Additional Manufacturer Narrative
(b)(4) cls information: brand name: evoke closed loop stimulator (cls) model: 102901 catalog: 3042 lot/batch number: 211e21 udi: (b)(4) expiration date: 10april2027.The replaced lead was not returned to saluda.The root cause of the lead migration could not be definitively determined; however, the physician noted that the patient¿s activity level following implantation may have contributed to the lead migration.The evoke scs system surgical guide detail 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¿.The discomfort at the cls implant site was associated to the patient¿s belt line.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "temporary or persistent post-surgical pain at hardware implantation sites and the patient may require surgery (including revision, explant, and replacement) as result¿.

• 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 ; AS 2113
• Manufacturer (Section G): Saluda Medical Pty Ltd; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 50754797
• Report Number: 3021836309-2026-00276
• Device Sequence Number: 9361611
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/14/2026

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 Model Number: 104523
• Device Catalogue Number: 3043
• Device Lot Number: 9018427705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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: Unknown