MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD DIRECT CLAMP ACTIVE ANCHOR KIT; SCS DIRECT ACTIVE ANCHOR

Model Number	104523
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system experienced midline incision dehiscence following multiple falls unrelated to the evoke scs system.The leads were observed to be protruding through the incision site.No signs of infection were noted.X-ray identified lead migration.The evoke scs system was explanted and antibiotics were administered.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.Additional lead info: product description: evoke cap12 percutaneous lead kit - 60cm.Model # : 102878.Catalog#: 3008.Serial/lot #: (b)(6).Product description: evoke cap12 percutaneous lead kit - 60cm.Model # : 102878.Catalog#: 3008.Serial/lot #: (b)(6).

• Brand Name: DIRECT CLAMP ACTIVE ANCHOR KIT
• Common Device Name: SCS DIRECT ACTIVE 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: 25470804
• Report Number: 3021836309-2026-00181
• Device Sequence Number: 15935971
• Product Code: LGW
• UDI-Device Identifier: 09352307001817
• UDI-Public: 09352307001817
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 9018143602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 10/15/2024
• 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