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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/10/2025
Type of Reportable Event Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system requested a system explant.The patient reported that their pain which was being treated by the evoke scs had been resolved.The evoke scs system was confirmed to be functioning as intended prior to the explant.
 
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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
AU  2113
MDR Report Key23680511
Report Number3016111136-2025-00209
Device Sequence Number15923192
Product Code LGW
UDI-Device Identifier09352307001565
UDI-Public09352307001565
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/01/2025
Report Date (Section F) 11/10/2025
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 Date12/15/2025
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 Date11/10/2025
Event Location Hospital
Date Report to Manufacturer11/10/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/01/2025
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexMale
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