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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD DIRECT CLAMP ACTIVE ANCHOR KIT; SCS DIRECT CLAMP ACTIVE ANCHOR
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SALUDA MEDICAL PTY LTD DIRECT CLAMP ACTIVE ANCHOR KIT; SCS DIRECT CLAMP ACTIVE ANCHOR Back to Search Results
Model Number 104523
Medical Device Problem Codes Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 04/13/2026
Type of Reportable Event Other
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for a change in stimulation.An x-ray confirmed lead migration.Reprograming was performed but unsuccessful.A revision procedure was performed, and the leads and anchors were replaced.
 
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Brand Name
DIRECT CLAMP ACTIVE ANCHOR KIT
Common Device Name
SCS DIRECT CLAMP ACTIVE ANCHOR
Manufacturer (Section D)
SALUDA MEDICAL PTY LTD
5 eden park drive
macquarie park, nsw 2113
AU  2113
MDR Report Key25125490
Report Number3016111136-2026-00100
Device Sequence Number21493197
Product Code LGW
UDI-Device Identifier09352307001817
UDI-Public09352307001817
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/08/2026
Report Date (Section F) 04/13/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number104523
Device Catalogue Number3043
Device Lot Number9018216303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/13/2026
Event Location Hospital
Date Report to Manufacturer04/13/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/08/2026
Date Device Manufactured10/29/2024
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 Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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