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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Saluda Medical PTY LTD Evoke Closed Loop Stimulator (CLS) (US); SCS IPG
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Saluda Medical PTY LTD Evoke Closed Loop Stimulator (CLS) (US); SCS IPG Back to Search Results
Model Number 101144
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Date of Event 07/21/2026
Type of Reportable Event Serious Injury
Event or Problem Description
During a full system explant of the evoke spinal cord stimulation (scs) system, a cerebrospinal fluid leakage (csf) occurred.The patient was transported to the hospital, and no additional information was provided.The reason for the full system explant of the evoke scs system was not disclosed to saluda.
 
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Brand Name
Evoke Closed Loop Stimulator (CLS) (US)
Common Device Name
SCS IPG
Manufacturer (Section D)
Saluda Medical PTY LTD
5 eden park drive
macquarie park, nsw 2113
AS  2113
MDR Report Key50275259
Report Number3016111136-2026-00166
Device Sequence Number10379196
Product Code LGW
UDI-Device Identifier09352307001565
UDI-Public09352307001565
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
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) 08/17/2026
Report Date (Section F) 08/17/2026
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 Date10/31/2025
Device Model Number101144
Device Catalogue Number3002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/21/2026
Event Location Hospital
Date Report to Manufacturer07/21/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/17/2026
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured02/06/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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