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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 Temperature Problem (3022)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/11/2026
Type of Reportable Event Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported the evoke closed loop stimulator (cls) felt warm during stimulation; therefore, the cls has been switched off.A revision procedure was performed, and the cls was replaced to resolve the reported event.
 
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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 Key25362205
Report Number3016111136-2026-00118
Device Sequence Number9984732
Product Code LGW
UDI-Device Identifier09352307001565
UDI-Public09352307001565
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
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) 06/02/2026
Report Date (Section F) 05/11/2026
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 Number101144
Device Catalogue Number3002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/11/2026
Event Location Hospital
Date Report to Manufacturer05/11/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/02/2026
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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